Skin treatment devices with tensioning features

ABSTRACT

The devices, kits and methods described may be used for wound healing, including the treatment, amelioration, or prevention of scars and/or keloids by applying and/or maintaining a pre-determined strain in an elastic skin treatment device that is then affixed to the skin surface using skin adhesives to transfer a generally planar force from the bandage to the skin surface. Applicators are used to apply and/or maintain the strains, and some of the applicators are further configured to provide at least some mechanical advantage to the user when exerting loads onto the skin treatment device.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.13/089,129, filed Apr. 18, 2011, which is a continuation of U.S.application Ser. No. 12/854,859, filed Aug. 11, 2010, which claimsbenefit under 35 U.S.C. §119(e) to U.S. Provisional Application Ser. No.61/233,122, filed Aug. 11, 2009, U.S. Provisional Application Ser. No.61/243,020, filed Sep. 16, 2009, and U.S. Provisional Application Ser.No. 61/264,205, filed Nov. 24, 2009, all of which are herebyincorporated by reference in their entirety. This application is alsorelated to U.S. application Ser. No. 11/888,978, filed Aug. 3, 2007issued as U.S. Pat. No. 7,683,234 on Mar. 23, 2010, U.S. patentapplication Ser. No. 12/358,162, filed Jan. 22, 2009 issued as U.S. Pat.No. 8,168,850 on May 1, 2012, and U.S. patent application Ser. No.12/358,164, filed Jan. 22, 2009 issued as U.S. Pat. No. 8,183,428 on May22, 2012, which are hereby incorporated by reference in their entirety.

BACKGROUND

Scar formation in response to cutaneous injury is part of the naturalwound healing process. Wound healing is a lengthy and continuousprocess, although it is typically recognized as occurring in stages. Theprocess begins immediately after injury, with an inflammatory stage.During this stage, which typically lasts from two days to one week(depending on the wound), damaged tissues and foreign matter are removedfrom the wound. The proliferative stage occurs at a time after theinflammatory stage and is characterized by fibroblast proliferation andcollagen and proteoglycan production. It is during the proliferativestage that the extracellular matrix is synthesized in order to providestructural integrity to the wound. The proliferative stage usually lastsabout four days to several weeks, depending on the nature of the wound,and it is during this stage when hypertrophic scars usually form. Thelast stage is called the remodeling stage. During the remodeling stagethe previously constructed and randomly organized matrix is remodeledinto an organized structure that is highly cross-linked and aligned toincrease mechanical strength.

While the histological features characterizing hypertrophic scars havebeen well documented, the underlying pathophysiology is not well known.Hypertrophic scars are a side effect of excessive wound healing, andgenerally result in the overproduction of cells, collagen, andproteoglycans. Typically, these scars are raised and are characterizedby the random distribution of tissue bundles. The appearance (i.e.,size, shape, and color) of these scars varies depending on the part ofthe body in which they form, and the underlying ethnicity of the personaffected. Hypertrophic scars are very common, and may occur followingany full thickness injury to the skin. Recently, it has been shown inU.S. Patent Application Publication 2006/0037091 (U.S. patentapplication Ser. No. 11/135,992 entitled “Method for ProducingHypertrophic Scarring Animal Model for Identification of Agents forPrevention and Treatment of Human Hypertrophic Scarring,” filed May 24,2005) which is hereby incorporated by reference in its entirety, thatmechanical stress may increase hypertrophic scarring in a murine model.

Keloids are typically characterized as tumors consisting of highlyhyperplastic masses that occur in the dermis and adjacent subcutaneoustissue in susceptible individuals, most commonly following trauma.Keloids are often more severe than hypertrophic scars, since they tendto invade normal adjacent tissue, while hypertrophic scars tend toremain confined within the original scar border.

Previous attempts to treat scars and keloids have included surgery,silicone dressings, steroids, x-ray irradiation, and cryotherapy. Eachof these techniques has disadvantages. Perhaps the biggest disadvantageis that none of them effectively prevent or ameliorate the formation ofscars or keloids in the first instance. That is, these techniques haveprimarily been used to treat scars after they are already wellestablished.

BRIEF SUMMARY

Devices, kits and methods described herein may be for wound healing,including the treatment, amelioration, or prevention of scars and/orkeloids by applying and/or maintaining a pre-determined strain in anelastic skin treatment device that is then affixed to the skin surfaceusing skin adhesives to transfer a generally planar force from thebandage to the skin surface. Applicators are used to apply and/ormaintain the strains, and some of the applicators are further configuredto provide at least some mechanical advantage to the user when exertingloads onto the skin treatment device.

In one variation, a device for treating a skin surface is provided,comprising a first device attachment member comprising a first pluralityof outwardly oriented projections, a second device attachment membercomprising a second plurality of outwardly oriented projections, and aresilient member configured to exert a separation force between thefirst and second device attachment members. The device may furthercomprise a releasable locking mechanism configured to maintain theresilient member in a retracted configuration, and wherein the retractedconfiguration may be a strained configuration. The releasable lockingmechanism may comprise a releasable latch, which may be configured tolock at a pre-determined strain and optionally resist further strainingwhen locked at the pre-determined strain, or even a plurality ofpre-determined strains. In some variations, the first device attachmentmember, the second device attachment member and the resilient member maybe integrally formed.

In another variation, a wound dressing device is provided, comprising anapplicator configured to maintain an attached dressing in a strainedconfiguration, and wherein the applicator comprises a first attachmentregion, a second attachment region, and an access region between thefirst and second attachment regions configured to provide access to anattached dressing when the dressing is in a strained configuration.

In another variation, a wound dressing is provided, comprising asilicone sheet structure comprising an upper surface, a lower surface, afirst edge and a second edge opposite the first edge, a first adhesiveregion, a second adhesive region spaced apart from the first adhesiveregion by a non-adhesive region, a first flap region located between thefirst edge and the first adhesive region, a second flap region locatedbetween the second edge and the second adhesive region, a firstapplicator attachment site located between the first flap region and thefirst adhesive region, and a second applicator attachment site locatedbetween the second flap region and the second adhesive region. The wounddressing may further comprise a first release liner releasably attachedto the first adhesive region and the second adhesive region. In somefurther variations, the first and/or second flap regions may be adhesiveflap regions, which may have a second and/or third release linerreleasably attached to them, respectively. The first and second adhesiveregions may comprise a pressure sensitive silicone adhesive with arelease force of at least about 240 kg/m, about 270 kg/m, about 300kg/m, or about 330 kg/m. The first applicator attachment site comprisesa plurality of attachment openings or a pocket structure. The firstrelease liner may have a lower surface and an upper surface with adifferent surface texture than the lower surface.

In still another variation, a dressing is provided, comprising anelastic layer comprising an upper surface, a lower surface, a firstedge, a second edge, a first applicator attachment site, a flap regionbetween the first edge and the first applicator attachment site, asecond applicator attachment site spaced away from the second edge, anda first adhesive region located on the lower surface of the elasticlayer.

In another variation, a method for treating a wound is provided,comprising straining an inner region of an elastic bandage between afirst unstrained region and a second unstrained region, wherein eachunstrained region is spaced away from two opposing edges of the bandage,and attaching the strained inner region of the bandage to a skin site.The straining of the inner region of the elastic bandage may beperformed before attaching the strained inner region of the bandage tothe skin site. In some further variations, attaching the strained innerregion of the bandage to the skin site may be performed withoutattaching the two opposing edges of the bandage to the skin site. Themethod may also further comprise attaching the two opposing edges of thebandage to the skin site after attaching the inner region of the bandageto the skin site, reducing peak strain in the attached bandage whileincreasing peak strain at the skin site, and/or attaching the twoopposing edges of the bandage to the skin site, which may includestraining the unstrained regions of the bandage before attaching the twoopposing edges of the bandage to the skin site. Straining the innerregion of the unattached elastic bandage may comprise stretching theinner region of the unattached elastic bandage to a pre-determinedstrain.

In one embodiment, a dressing is provided, comprising an elastic layercomprising an upper surface, a lower surface, a first edge, a secondedge, a first applicator attachment site, a flap region between thefirst edge and the first applicator attachment site, a second applicatorattachment site spaced away from the second edge, and a first adhesiveregion located on the lower surface of the elastic layer.

In another embodiment, a method for treating a wound is provide,comprising straining an inner region of an elastic bandage between afirst unstrained region and a second unstrained region, wherein eachunstrained region is spaced away from two opposing edges of the bandage,and attaching the strained inner region of the bandage to a skin site.Straining the inner region of the elastic bandage may be performedbefore attaching the strained inner region of the bandage to the skinsite. Attaching the strained inner region of the bandage to the skinsite may be performed without attaching the two opposing edges of thebandage to the skin site. The method may further comprise attaching thetwo opposing edges of the bandage to the skin site after attaching theinner region of the bandage to the skin site. The method may furthercomprise reducing peak strain in the attached bandage while increasingpeak strain at the skin site. The method may further comprise attachingthe two opposing edges of the bandage to the skin site. The method mayfurther comprise straining the unstrained regions of the bandage beforeattaching the two opposing edges of the bandage to the skin site.Straining the inner region of the unattached elastic bandage maycomprise stretching the inner region of the unattached elastic bandageto a pre-determined strain.

In still another embodiment, an incision treatment system is provided,comprising an elastic member comprising at least two hook-and-loopregions and at least one skin adhesive region. The elastic member may bean elastic layer member. The at least one adhesive region may be locatedon an opposite surface of the elastic member than the at least twohook-and-loop regions. Each of the at least two hook-and-loop regionsmay be loop-type of hook-and-loop regions. The elastic member maycomprise at least two skin adhesive regions. The incision treatmentsystem may further comprise an applicator comprising at least twohook-and-loop regions complementary to the at least two hook-and loopregions of the elastic member.

In one embodiment, a system for treating a skin surface is provided,comprising a tensioning member, comprising a first device attachmentmember, a second device attachment member, and a collapsible structureconfigured to movably separate the first and second device attachmentmembers without requiring continuous application of external force ontothe device to maintain separation of the first and second deviceattachment members. The system may further comprise an elastic memberconfigured to attach to the first and second device attachment membersof the tensioning member. The elastic member may be configured toreleasably attach to the first and second device attachment members ofthe tensioning member. The elastic material may have a load per width ofat least 0.35 Newtons per mm at an engineering strain of 60%. Theelastic material may have a load per width of no greater than about 2Newtons per mm at the engineering strain of 60%, about 1 Newtons per mmat the engineering strain of 60%, about 0.7 Newtons per mm at theengineering strain of 60%, or no greater than about 0.5 Newtons per mmat the engineering strain of 60%. The system elastic material may have aload per width that does not decrease from an engineering strain of 0%to 60%, a load per width plot that increases linearly from anengineering strain of 0% to 60%, or a load per width plot that is notconvex from an engineering strain of 0% to 60%. The elastic material maycomprise an adhesive configured to maintain a substantially constantstress in the range of 200 kPa to about 500 kPa for at least 8 hourswhen strained to an engineering strain of 30% and attached to a surface.The elastic material may comprise an adhesive configured to maintain asubstantially constant stress in the range of 200 kPa to about 400 kPafor at least 8 hours when strained to an engineering strain of 30% andattached to a surface. The substantially constant stress may vary byless than 10% over at least 8 hours, or by less than 5% over at least 8hours. The collapsible structure may comprise two collapsible supportsand two rigid supports. Each of the two collapsible supports mayarticulate with both of the two rigid supports. The two collapsiblesupports may each comprise two pivotably connected subsupports. Thecollapsible structure may comprise a collapsed state and an expandedstate, and in the collapsed state, each of the pivotably connectedsubsupports form an angle of at least 30 degrees with a line thatbisects the two collapsible supports. The system may further comprise astamping structure configured to pass a user-exerted force through thecollapsible structure. The stamping structure may comprise a stampingsurface and a resilient member. The resilient member may be a spring.The two rigid supports may have a substantially parallel orientation andat least one of the two rigid supports is configured to translate alonga movement axis perpendicular to the parallel orientation. Thecollapsible structure may be configured to provide a mechanicaladvantage when exerting the separation force. The mechanical advantagemay be provided throughout a movement range of the collapsiblestructure, or may be provided partially through a movement range of thecollapsible structure.

In one embodiment, a tensioning device configured to exert a separationforce to cause a strain in a skin treatment device may be provided, thetensioning device comprising a tensioning member, and a first attachmentportion configured to releasably attach to a skin treatment device and asecond attachment portion configured to releasable attach to the skintreatment device, wherein the tensioning member may be configured toexert a separation force between the first attachment portion and thesecond attachment portion to cause a strain in a skin treatment deviceattached to the first and second attachment portions. The tensioningmember may be configured to strain the skin treatment device to anengineering strain of 40% using a load of at least about 0.25 Newtonsper mm width of the skin treatment device. The load to strain the skintreatment device to the engineering strain of 40% may be no greater thanabout 1 Newton per mm width of the skin treatment device, and may be nogreater than about 0.5 Newton per mm width of the skin treatment device.In other embodiments, the tensioning member may be configured to strainthe skin treatment device to an engineering strain of 60% using a loadof at least about 0.35 Newtons per mm width of the skin treatmentdevice. The load to strain the skin treatment device to the engineeringstrain of 60% may be no greater than about 1 Newton per mm width of theskin treatment device. The tensioning member may comprise a resilientmember configured to exert the separation force. The tensioning devicemay further comprise a compressing member configured to retract theresilient member to a first configuration and then to release theresilient member to a strained configuration whereby a strain may beproduced in a skin treatment device attached to the first and secondattachment portions. The tensioning device may further comprise areleasable locking mechanism configured to releasably lock the resilientmember in the first configuration. The locking mechanism may beconfigured to lock across a range of resilient member configurationscorresponding to a range of predetermined strains in the skin treatmentdevice. The locking mechanism may be configured to lock across a rangeof predetermined strains within a range from about 0% to about 60%, or arange from about 10% to about 50%. The tensioning member may comprise amechanical force applicator configured to exert the separation force.The mechanical force applicator may provide a mechanical advantage toapply the force. The mechanical force applicator may be manuallyactuatable. At least one the first and second attachment portions maycomprise a hook and loop mechanism. At least one of the first and secondattachment portions may comprise an extension member configured to bereceived in an opening in a skin treatment device. At least one of thefirst and second attachment portions may comprise an opening forreceiving an attachment member of a skin treatment device. At least oneof the first attachment portion and the second attachment portion may beconfigured to move relative to the tensioning member to facilitateseparation of the skin treatment device. At least one of the firstattachment portion and the second attachment portion may be configuredto pivot or rotate relative to the tensioning member. At least one ofthe first attachment portion and the second attachment portion may beconfigured to retract relative to the tensioning member. The tensioningdevice may be an applicator configured to permit a user to apply a skintreatment device to skin of a subject. The tensioning device may furthercomprise pressure pads configured to apply pressure to a skin treatmentdevice being applied to skin of a subject. The pressure pads may belocated between the first and second attachment portions. The tensioningmember may have a curved configuration, which may also be a curvedplanar configuration. The tensioning member may be configured toautomatically lock upon deformation to a predetermined lockingconfiguration.

In another embodiment, a method of applying a treatment device to asurface is provided, comprising actuating the tensioning device tostrain a treatment device to at least a predetermined strain threshold,maintaining a strain in the treatment device without requiring externalapplication of force onto the tensioning device, applying the strainedtreatment device to a treatment site, and detaching the treatment devicefrom the tensioning device. The method may further comprise attachingthe treatment device to the tensioning device before actuating thetensioning device. Actuating the tensioning device may comprisesqueezing the tensioning device. The method may further compriserelieving at least some of the strain in the treatment device. Relievingat least some of the strain in the treatment device may comprisecollapsing the tensioning device. The method may further compriselocking the tensioning device to a predetermined configuration actuatingthe tensioning device. Locking the tensioning device may occurautomatically after straining the treatment device to the predeterminedstrain threshold. Relieving the strain may comprise in the treatmentdevice may comprise unlocking a locking mechanism of the tensioningdevice. Attaching the treatment device to the tensioning device maycomprise attaching the treatment device to the tensioning device mayoccur at two separate locations using two attachment mechanisms locatedon the tensioning device. The method may further comprise pressing thetreatment device against the treatment site. Pressing the treatmentdevice may occur before detaching the treatment device from thetensioning device. Pressing the treatment device may comprise pushingdown a resilient stamper mechanism located between the two attachmentmechanisms of the tensioning device, or reaching into an access openingin the tensioning device to manually push on the treatment device.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A is a schematic superior view of one variation of a woundtreatment device; FIG. 1B is a schematic side elevational view of thewound treatment device in FIG. 1A;

FIGS. 2A and 2B are schematic superior and side elevational views of thewound treatment in FIGS. 1A and 1B, respectively, with release liners;FIG. 2C is a superior component view of the release liners in FIGS. 2Aand 2B;

FIG. 3A is a perspective view of a wound treatment applicator in a baseconfiguration; FIGS. 3B to 3D are side elevational, superior andinferior views of the applicator in FIG. 3A;

FIGS. 4A to 4D are perspective, side elevational, superior and inferiorviews of the applicator in FIGS. 3A to 3D in a locked configuration;

FIGS. 5A and 5B are schematic perspective and side elevational views ofthe applicator in FIGS. 4A and 4B loaded with a wound treatment device;

FIG. 6 depicts another variation of an applicator;

FIG. 7 schematically depicts another variation of an applicator with twosets of central panels and locking mechanisms;

FIG. 8 schematically depicts another variation of an applicator withhinged base structures;

FIG. 9 schematically depicts another variation of an applicator withbendable wire-supported base structures;

FIG. 10 is a schematic front elevational view of a curved attachmentstructure of an applicator;

FIGS. 11A and 11B are schematic side elevational views of an applicatorwith a hinged frame in an unlocked and locked configuration,respectively.

FIG. 12A is a schematic superior view of an applicator with pneumaticstrut members; FIG. 12B is a schematic component view of the ratchetlocking mechanism of the applicator in FIG. 12A; and

FIGS. 13A to 13D schematically depict one variation of the use of thewound treatment device depicted in FIGS. 1A and 1B.

FIGS. 14A and 14B illustrate engineering and true stress/strain plots,respectively, of STERI-STRIP™ material.

FIGS. 15A and 15B illustrate engineering and true stress/strain plots,respectively, of BAND-AID® Flexible Fabric backing material.

FIGS. 16A and 16B illustrate engineering and true stress/strain plots,respectively, of an intact BAND-AID® Flexible Fabric bandage.

FIGS. 17A and 17B illustrate engineering and true stress/strain plots,respectively, of BAND-AID® TOUGH STRIP™ backing material.

FIGS. 18A and 18B illustrate engineering and true stress/strain plots,respectively, of an intact BAND-AID® TOUGH STRIP™ bandage.

FIGS. 19A and 19B illustrate engineering and true stress/strain plots,respectively, of NEXCARE™ TEGADERM™ backing material.

FIGS. 20A and 20B illustrate engineering and true stress/strain plots,respectively, of an intact NEXCARE™ TEGADERM™ bandage.

FIGS. 21A and 21B illustrate engineering and true stress/strain plots,respectively, of one embodiment of a backing material configured toimpose a skin strain using a predetermined strain in the backingmaterial.

FIGS. 22A and 22B illustrate engineering and true stress/strain plots,respectively, of elastic Steri-Strip™ material.

FIGS. 23A and 23B illustrate engineering and true stress/strain plots,respectively, of BAND-AID® ULTRA STRIP® backing material.

FIGS. 24A and 24B illustrate engineering and true stress/strain plots,respectively, of an intact BAND-AID® ULTRA STRIP® bandage.

FIGS. 25A and 25B illustrate engineering and true stress/strain plots,respectively, of DuoDERM® Extra Thin material.

FIGS. 26A and 26B illustrate engineering and true stress/strain plots,respectively, of CVS/Pharmacy® silicone scar sheet backing material.

FIGS. 27A and 27B illustrate engineering and true stress/strain plots,respectively, of CVS/Pharmacy® self-adherent gentle wrap material.

FIGS. 28A and 28B illustrate engineering and true stress/strain plots,respectively, of DuoDERM® CGF® material.

FIGS. 29A and 29B illustrate engineering and true stress/strain plots,respectively, of CVS/Pharmacy® elastic bandage material.

FIGS. 30A to 30C depict load per width plots of various bandagematerials using three different Y-axis scales, respectively.

FIGS. 31A and 31B are engineering stress plots over time for theNexcare™ Tegaderm™ under different loads using different X-axis scales,respectively.

FIGS. 32A and 32B are engineering stress plots over time for the GLYDe-Mdevice under different loads using different X-axis scales,respectively.

FIGS. 33A and 33B are engineering stress plots over time for the elasticSteri-Strip™ under different loads using different X-axis scales,respectively.

FIGS. 34A and 34B are engineering stress plots over time for Band-Aid®Ultra Strip® backing material under different loads using differentX-axis scales, respectively.

FIGS. 35A and 35B are engineering stress plots over time for theBand-Aid® Flexible Fabric under different loads using different X-axisscales, respectively.

FIGS. 36A and 36B are engineering stress plots over time forCVS/Pharmacy® silicone scar sheeting under different loads usingdifferent X-axis scales, respectively.

FIGS. 37A and 37B are engineering stress plots over time for DuoDERM®Extra Thin under different loads using different X-axis scales,respectively.

FIGS. 38A and 38B are engineering stress plots over time for DuoDERM®CGF® under different loads using different X-axis scales, respectively.

FIGS. 39A and 39B are engineering stress plots over time forCVS/Pharmacy® elastic bandage under different loads using differentX-axis scales, respectively.

FIGS. 40A and 40B are engineering stress plots over time for theCVS/Pharmacy® self-adherent gentle wrap under different loads usingdifferent X-axis scales, respectively.

FIGS. 41A and 41B illustrate engineering and true stress/strain plots,respectively, of Smith & Nephew OpSite™.

FIGS. 42A to 42C are superior, cross sectional and side elevationalviews of a dressing comprising pockets.

FIGS. 43A to 43C are cross sectional views of alternate embodiments of adressing comprising pockets.

FIGS. 44A and 44B are superior and cross sectional views of anotherdressing comprising T-tag attachment structures.

FIGS. 45A and 45B are superior and cross sectional views of anotherdressing comprising eyelet attachment structures.

FIGS. 46A to 46C are superior, cross sectional and side elevationalviews of another dressing comprising a hook-and-loop type of attachmentstructure.

FIG. 47 depicts an applicator with corresponding hook-and-loop type ofattachment structures configured for use with the dressing in FIGS. 46Ato 46C.

FIG. 48 depicts another applicator with corresponding hook-and-loop typeof attachment structures configured for use with the dressing in FIGS.46A to 46C.

FIGS. 49A to 49B depicts another applicator with hook-and-loop type ofattachment structures.

FIG. 50A is a perspective view of an applicator in an unstrainedconfiguration; FIG. 50B is a perspective view of the applicator of FIG.50A in a strained configuration; FIG. 50C is a side elevational view ofa handle and locking mechanism of the applicator of FIG. 50A in anunstrained configuration; FIG. 50D is a side elevational view of ahandle and locking mechanism of the applicator of FIG. 50A in a strainedconfiguration; FIG. 50E is a superior view of the applicator of FIG. 50Ain a strained configuration; and FIG. 50F is a side elevational view ofthe applicator of FIG. 50A in a strained configuration.

FIG. 51A is a perspective view of an applicator in an unstrainedconfiguration; FIG. 51B is a perspective view of the applicator of FIG.51A in a strained configuration; FIG. 51C is a anterior view of theapplicator of FIG. 51A in an unstrained configuration; FIG. 51D is afront side view of an applicator of FIG. 51A in a strainedconfiguration.

FIG. 52A is a perspective view of an applicator in an unstrainedconfiguration; FIG. 52B is a perspective view of the applicator of FIG.52A applicator in a strained configuration; FIG. 52C is an inferior viewof the applicator of FIG. 52A in an unstrained configuration; FIG. 52Dis an inferior view of the applicator of FIG. 52A in a strainedconfiguration; FIG. 52E is a superior view of the applicator of FIG. 52Ain an unstrained configuration; FIG. 52F is a superior view of theapplicator of FIG. 52A in a strained configuration; FIG. 52G is across-sectional view of the applicator of FIG. 52E along the lines A-Ain an unstrained configuration; and FIG. 52H is a cross-sectional viewof an applicator of FIG. 52F along the lines B-B in a strainedconfiguration.

FIG. 53A is a perspective view of an applicator in an unstrainedconfiguration; FIG. 53B is a perspective view of the applicator of FIG.53A applicator in a strained configuration; FIG. 53C is an inferior viewof the applicator of FIG. 53A in an unstrained configuration; FIG. 53Dis an inferior view of the applicator of FIG. 53A in a strainedconfiguration; and FIG. 53E is a superior view of the applicator of FIG.53A in a strained configuration.

FIG. 54A is a superior view of an applicator in an unstrainedconfiguration; FIG. 54B is a superior view of the applicator of FIG. 54Ain a strained configuration; FIG. 54C is an inferior perspective view ofthe applicator of FIG. 54A in an unstrained configuration; FIG. 54D isan inferior perspective view of the applicator of FIG. 54A in a strainedconfiguration; FIG. 54E is a perspective view of the applicator withintegrated stamper, in an unstrained configuration; FIG. 54F is aperspective view of the applicator of FIG. 54E in a strainedconfiguration; FIG. 54G is a side view of the applicator of FIG. 54E inan unstrained configuration; FIG. 54H is a side view of the applicatorof FIG. 54E in a strained configuration; and FIG. 54I is a side view ofthe applicator of FIG. 54E in a strained configuration with a deployedstamper.

FIG. 54J is a schematic illustration and equation to determine themechanical advantage of a collapsing box applicator design; FIG. 54K isa table listing the input load and output load of one embodiment of acollapsing box applicator for strains from 0% to 40%; FIG. 54L is agraph of the input and output loads per strain of the data from FIG.54K; FIG. 54M is a table listing the input load and output load ofanother embodiment of a collapsing box applicator for strains from 0% to60%; FIG. 54N is a graph of the input and output loads per strain of thedata from FIG. 54M up to 40% strain; FIG. 54O is a table listing theinput load against a constant output load of the collapsing boxapplicator embodiment from FIGS. 54M and 54N for strains from 0% to 60%;FIG. 54P is a graph of the input and output loads per strain of the datafrom FIG. 54O;

FIG. 55A is a perspective view of an applicator with an integrated foamstamper in an unstrained configuration; FIG. 55B is a perspective viewof the applicator of FIG. 55A in a strained configuration; FIG. 55C is aside partial cut-away view of the applicator of 55A in an unstrainedconfiguration; FIG. 55D is an inferior view of the applicator of FIG.55A in a strained configuration; and FIG. 55E is an inferior view of theapplicator of FIG. 55A in a strained configuration

FIG. 56A is a perspective view of an applicator with an integrated foamstamper in an unstrained configuration; FIG. 56B is a perspective viewof the applicator of FIG. 56A in a strained configuration; FIG. 56C is aperspective view of the tensioning device of the applicator of FIG. 56Ain an unstrained configuration; FIG. 56D is a perspective view of thetensioning device of the applicator of FIG. 56A in a strainedconfiguration; and FIG. 56E is a side cross sectional view of theapplicator of FIG. 56A in an unstrained configuration.

FIG. 57A is a perspective view of an applicator with an integrated foamstamper in an unstrained configuration; FIG. 57B is a perspective viewof the applicator of FIG. 57A in a strained configuration; FIG. 57C isan inferior view of the tensioning device of the applicator of FIG. 57Ain an unstrained configuration; FIG. 57D is an inferior view of thetensioning device of the applicator of FIG. 57A in a strainedconfiguration; FIG. 57E is a front elevational view of the tensioningdevice of the applicator of FIG. 57A in an unstrained configuration;FIG. 57F is a cross sectional view of the device as indicated in FIG.57E; FIG. 57G is a side elevational view of the tensioning device of theapplicator of FIG. 57A in a strained and stamped configuration; FIG. 57His a cross sectional view of the device as indicated in FIG. 57G; andFIG. 57I is a partial cut-away perspective view of the tensioning deviceof the applicator of FIG. 57A in a strained configuration.

FIG. 58A is a perspective view of an applicator in an unstrainedconfiguration; FIG. 58B is a side view of the applicator of FIG. 58A inan unstrained configuration; FIG. 58C is a side view of the applicatorof FIG. 58A in a strained configuration; FIG. 58D is a side view of theapplicator of FIG. 58A in a strained and stamped configuration; FIG. 58Eis a superior view of the applicator of 58A in a strained, stamped andunreleased configuration; FIG. 58F is a cross-sectional view of theapplicator of FIG. 58E along the lines A-A; FIG. 58G is a superior viewof the applicator of 58A in a strained, stamped and releasedconfiguration; FIG. 58H is a cross-sectional view of the applicator ofFIG. 58G along the lines A-A; and FIG. 58I is a cross-sectional view ofthe applicator of FIG. 58G along the lines B-B.

FIG. 59A is a perspective view of an applicator in an unstrainedconfiguration; FIG. 59B is a side view of the applicator of FIG. 59A inan unstrained configuration; FIG. 59C is a side view of the applicatorof FIG. 59A in a strained an unstamped configuration; and FIG. 59D is aside view of the applicator of FIG. 59A in a strained and stampedconfiguration.

FIG. 60A is a perspective view of an applicator and skin treatmentdevice in an unstrained configuration; FIG. 60B is a perspective view ofthe applicator and skin treatment device of FIG. 60A in a strainedconfiguration; FIG. 60C is a perspective view of the applicator and skintreatment device of FIG. 60A in an applied and released configuration;and FIG. 60D is a perspective view of an applicator with an integratedfoam stamper in an unstrained configuration.

FIG. 61A is a perspective view of an applicator in a strainedconfiguration; FIG. 61B is a perspective view of the applicator of FIG.61A in an unstrained configuration with the attachment feet released(unconstrained); FIG. 61C is a superior view of the applicator of FIG.61A in a strained configuration; FIG. 61D is a side cross section viewacross the lines A-A of a portion of the applicator of FIG. 61C; FIG.61E is a superior view of the applicator of FIG. 61A in an unstrainedconfiguration; and FIG. 61F is a side cross sectional view across thelines A-A of a portion of the applicator of FIG. 61E.

FIG. 62A is a perspective view of an applicator and skin treatmentdevice in an unstrained configuration; FIG. 62B is a perspective view ofthe applicator and skin treatment device of FIG. 62A in a releasedconfiguration; FIG. 62C is a perspective view of the applicator and skintreatment device of FIG. 62A in a strained configuration; and FIG. 62Dis a perspective view of the applicator and skin treatment device ofFIG. 62A in an applied configuration.

FIG. 63A is a perspective view of a variation of an attachment system inan unloaded configuration; and FIG. 63B is a perspective view of avariation of the attachment system of FIG. 63A in a loadedconfiguration.

FIGS. 64A to 64Q illustrate variations of an attachment system.

FIG. 65A is a perspective view of an attachment structure system in afirst position; FIG. 65B is a side view of the attachment structuresystem of FIG. 65A in the first position; and FIG. 65C is a side view ofthe attachment structure system of FIG. 65A in a second, retractedposition.

FIG. 66A is a superior view of a skin treatment device in a firstposition; and FIG. 66B is a superior view of the skin treatment deviceof FIG. 66A in a second position.

DETAILED DESCRIPTION

The mechanical environment of an injury may be an important factor intissue response to that injury. The mechanical environment includesexogenous stress (i.e., physiological stress which includes stresstransferred to the wound via muscle action or physical body movement)and endogenous stress (i.e., dermal stress originating from the physicalproperties of the skin itself, including stress induced at the woundsite due to swelling or contraction of the skin). The devices, bandages,kits and methods described herein may control or regulate the mechanicalenvironment of a wound to ameliorate scar and/or keloid formation. Themechanical environment of a wound includes stress, strain, and anycombination of stress and strain. The control of a wound's mechanicalenvironment may be active or passive, dynamic (e.g., by applying anoscillating stress) or static. The stresses and strains acting on thewound may involve the layers of the skin, such as the outer stratumcorneum, the epidermis and dermis, as well as the underlying connectivetissue layers, such as the subcutaneous fat. Devices and methodsdescribed here may shield a wound from its mechanical environment. Theterm “shield” is meant to encompass the unloading of stress experiencedby the wound as well as providing a physical barrier against contact,contaminants, and the like. The devices and methods described here mayshield a wound by unloading the wound and surrounding tissues fromendogenous stress and/or exogenous stress. Thus, devices and methodsdescribed here may reduce the stress experienced by a wound andsurrounding tissues to a lower level than that experienced by normalskin and tissue. Unloading of exogenous and/or endogenous stress in thevicinity of the wound may ameliorate the formation of scars,hypertrophic scars, or keloids.

A cell's external mechanical environment may trigger biologicalresponses inside the cells and change cell behavior. Cells can sense andrespond to changes in their mechanical environment using integrin, anintegral membrane protein in the plasma membrane of cells, andintracellular pathways. The intracellular pathways are initiated byreceptors attached to cell membranes and the cell membrane that cansense mechanical forces. For example, mechanical forces can inducesecretion of cytokines, chemokines, growth factors, and otherbiologically active compounds that can increase or trigger theinflammatory response. Such secretions can act in the cells that secretethem (intracrine), on the cells that secrete them (autocrine), on cellssurrounding the cells that secrete them (paracrine), or act at adistance from the point of secretion (endocrine). Intracrineinterference can alter cell signaling, which can in turn alter cellbehavior and biology including the recruitment of cells to the wound,proliferation of cells at the wound, and cell death in the wound. Inaddition, the extracellular matrix may be affected.

As noted above, the wound healing process may be characterized in threestages: early inflammatory phase, the proliferative phase, andremodeling. The inflammatory phase occurs immediately after injury andtypically lasts about two days to one week. Blood clotting takes placeto halt blood loss and factors are released to attract cells that canremove debris, bacteria and damaged tissue from the wound. In addition,factors are released to initiate the proliferative phase of woundhealing. In the proliferative phase, which lasts about four days toseveral weeks, fibroblasts grow and build a new extracellular matrix bysecreting collagen and proteoglycans. At the end of the proliferativephase, fibroblasts can act to contract the wound further. In theremodeling phase, randomly oriented collagen is organized andcrosslinked along skin tension lines. Cells that are no longer neededcan undergo apoptosis. The remodeling phase may continue for many weeksor months, or indefinitely after injury. Scars typically reach about75-80% of normal skin breaking strength about 6-8 weeks after injury. Ingeneral, scars typically have a triangular cross-section. That is, ascar is usually smallest in volume near the skin surface (i.e., stratumcorneum and epidermis) and increases in volume as it progresses into thedeeper layers of the dermis.

There are three common possible outcomes to a wound healing process.First, a normal scar can result. Second, a pathologic increase in scarformation can result, such as formation of a hypertrophic scar or akeloid. Third, the wound may not heal completely and become a chronicwound or ulcer. The devices, kits and methods described herein canameliorate the formation of any type of scar. In addition, the devices,kits and methods described here can be adapted for a variety of woundsizes, and for different thicknesses of skin, e.g., the devices may beconfigured for use in different areas of the body. In addition, thedevices, kits and methods described here can be adapted to amelioratescar formation in any type of skin, e.g., body location, age, race, orcondition.

Without wishing to be bound by any particular theory, we believe thatmechanical strain acting on a wound or incision early in theproliferative phase of the wound healing process may inhibit cellularapoptosis, leading to a significant accumulation of cells and matrix,and hence increased scarring or the production of hypertrophic scars.Given the underlying similarities between hypertrophic scars and keloidswith respect to excessive matrix formation, we believe that the devicesand methods described herein may also be useful in preventing andtreating keloids by offloading or neutralizing at least some of thestrain that may be acting on the wound or incision. This tensile strainmay be exogenous and/or endogenous strain, and may include but is notlimited to the strain from the intrinsic tensile forces found in normalintact skin tissue.

Devices are described here for ameliorating the formation of scarsand/or keloids at a wound site. The scars may be any type of scar, e.g.,a normal scar, a hypertrophic scar, etc. In general, the devices may beconfigured to be removably secured to a skin surface near a wound. Thedevices may shield the wound from endogenous stress and/or exogenousstress. In some variations, the devices may shield the wound fromendogenous stress without affecting exogenous stress on the wound, e.g.,devices that modify the elastic properties of the skin, etc. In othervariations, the devices may shield the wound from exogenous stresswithout affecting endogenous stress on the wound. Such variations mayinclude situations where the musculature and surrounding wound tissuehas been paralyzed, e.g., through the use of botulinum toxin or thelike. In still other variations, the devices shield the wound from bothendogenous and exogenous stress.

The devices, dressings and bandages described herein may ameliorate theformation of scars at wound sites by controllably stressing or strainingthe epidermis and deeper layers of dermal tissue around the wound,thereby reducing tensile or compressive stress at the wound site itself.The stress at the wound site may be reduced to levels below thatexperienced by normal skin and tissue. The stress or strain may beapplied to surrounding tissue in one, two, or three directions to reduceendogenous or exogenous stress at the wound in one, two or threedirections.

The physical characteristics of the device and/or the method of applyingthe device may also be further configured to resist or reduce the rateof skin stripping or tension blistering from the application of strainto the incision site.

FIGS. 1A and 1B depict one variation of a wound treatment device 2,comprising an elastic layer of material 4 with an upper surface 6, alower surface 8, and edges 10, 12, 14 and 16. The lower surface 8 of theelastic layer of material 4 may comprise a central non-adhesive region18 flanked by two inner adhesive regions 20 and 22 along borders 24 and26. In this particular variation, the central non-adhesive region 18also has two borders 28 and 30 which are adhesive-free. Thisconfiguration may facilitate the treatment of longer incisional sites byserially placing the non-adhesive regions of multiple wound treatmentdevices along the incisional site, without the device edges directlyadhering to the incisional site.

In some variations, the average width of the non-adhesive region, i.e.the distance between the adhesive regions along the axis of strain (orwhere the device is strained along multiple dimension, the largestdimension of the device 2 along one of its axes of strain), is in therange of about 3 mm to about 15 mm or more, in some variations about 5mm to about 10 mm, and in other variations about 7 mm to about 8 mm. Thewidth of the adhesive region may be the same or greater than the widthof the non-adhesive regions, including but not limited to being 2×, 3×,or 4× or more in relative width. In some variations, the greater widthof the adhesive regions relative to the non-adhesive region may lowerfocal concentrations of tissue stress, which may reduce tissue strippingand/or blistering. The widths of the non-adhesive region and/or theadhesive regions may be constant or may be variable, and the widths ofthe adhesive regions may be the same or different.

The inner adhesive regions 20 and 22 may comprise outer borders 32 and34 which are opposite of the inner borders 24 and 26 shared with thecentral non-adhesive region 18 and shared with the outer non-adhesiveregions 36 and 38. The non-adhesive regions 36 and 38 may furthercomprise applicator attachment regions or structures 40 and 42 that areconfigured to releasably attach to an applicator that may be used toapply the device 2 to a treatment site. In some further variations, theattachment structures may also facilitate stretching of the centraladhesive region 18 and/or the adhesive regions 20 and 22. Variousexamples of applicators that may be used are described in greater detailbelow. In other variations, the applicator attachment structures 40 and42 may be located in adhesive regions that may or may not be contiguouswith more inner adhesive regions. In other variations, the elasticmaterial about the attachment structures may comprise an adhesive.Examples of applicators are described in greater detail below.

The applicator attachment structures 40 and 42 may comprise a pluralityof openings 44 and 46 located through the layer of elastic material 4.The openings 44 and 46 may be through-openings between the upper andlower surfaces. In other variations, the openings may be close-endedopenings, e.g. a plurality of pockets or even a single pocket spanningthe width or a portion of the width of the device.

In the variation depicted in FIGS. 1A and 1B, the openings 44 and 46 areconfigured to be fully penetrated by the applicator, but in othervariations, the applicator and/or the openings may be configured foronly partial insertion by the applicator. The openings 44 and 46 may becircular, ovoid, triangular, rectangular, square, polygonal or any otherof a variety of shapes. Each of the openings may have the same or adifferent shape, size or configuration, and the shape, size orconfiguration may vary between the upper surface and the lower surface.The openings may be also be angled with respect to the upper surface orlower surface, and in some variations, one or more openings and/or aregion about the openings may be partially or completely reinforced bywires, rings and/or frames and the like. In some variations, theapplicator attachment structures may also comprise denser or thickerregions of the elastic material. In some variations, multiple sets ofapplicator attachment structures may be provided to permit use ofdifferent applicators or to strain the device to different degrees, forexample.

FIGS. 42A to 42C depict another variation of the dressing 600 comprisingpockets 602 and 604 with inwardly facing pocket openings 606 and 608configured to receive the attachment structures of a correspondingapplicator. The pockets may comprise separate sheets of material thatare attached to the elastic material and may comprise the same or adifferent material as the other portions of the dressing. The separatesheets of material may be adhered to the elastic material usingadhesives, heat or plasma bonding, chemical bonding or mechanicalattachment structures (e.g. staples and stitches). In the exampledepicted best in FIGS. 42B and 42C, the pockets 602 and 604 may beintegrally formed structures of the base layer 610 that are folded overfrom the ends 612 and 614 of the dressing 600 and attached onto itselfalong the edges 616 and 618 without bonding the opening edge 620 to formthe opening 606. In other variations, such as the dressing 630 depictedin FIG. 43A, the inner portions 632 of a pocket structure 634 or thedistal edge 636 may also be adhered or fused to form multiple subpockets638 and 640. Although FIG. 43A depicts a dressing with two subpockets638 and 640, in other variations, three, four, five, six, seven, eightor more subpockets may be provided. The area or width of the fused innerportion(s) 652 may also vary, as shown in the dressing 650 in FIG. 43B.The width of the fused inner portion(s) may be in the range of about 0.5mm to about 10 mm or more, sometimes about 1 mm to about 5 mm, and othertimes about 1 mm to about 2 mm. As shown in the dressing 660 of FIG.43C, in other variations, the subpockets 662 and 664 may also beseparately provided without an inner portion interconnecting them. Insome further variations, the opening(s) of the pocket structures may beclosed or sealed shut after application. Closure may result from usingan adhesive, complementary sealable groove structures about the pocketopenings (e.g. sandwich bag seal) or as a result of the cohesiveproperties of the elastic material when the pocket is pressed down.Closure of the pockets may reduce the risk of snagging the dressingfollowing its application.

In other variations, the applicator attachment structures may compriseone or more projections or other structures protruding from the surfaceof the wound treatment device that form a mechanical or frictionalinterfit with the applicator. Referring to FIGS. 44A to 45B, examples ofthese alternate attachment structures include T-bar 672 or eyeletprojections 682 of the dressings 670 and 680 that may be releasablyengaged by an applicator. The t-bar 672 and eyelet projections 682 maybe integrally formed with the base elastic layer 674 and 684 of thedressings 670 and 680, or may comprise a different material that ispartially embedded in the elastic layer 674 and 684. In still othervariations, the t-bar or eyelet projections may comprise individual orcommon base or pad structures that may be adhered to the surface of theelastic layer 674 and 684. The number of projecting attachmentstructures per side of the dressing may be in the range of about one toabout twelve or more, sometimes about three to about eight, and othertimes about four to about five.

In still another variation, the dressing may comprise complementaryhook-and-loop attachment regions (e.g. VELCRO®) that may releasablyattach to an applicator with a corresponding hook-and-loop attachmentregions. In FIGS. 46A to 46C, for example, the bandage 700 comprisesloop attachment regions 702 and 704 that are adhered to the uppersurface 706 of the bandage 700, and with various adhesive regions 708a/b and 710 a/b located on the lower surface 712. In use, acorresponding applicator, including but not limited to the exemplaryapplicator 714 depicted in FIG. 47, is squeezed or compressed to reducethe spacing between corresponding hook regions 716 and 718 to correspondto the spacing of the loop attachment regions 702 and 704 of the bandage700 in its unstretched state. The hook regions 716 and 718 are alignedand then pressed against the loop attachment regions 702 and 704 toengage the bandage 700. In some examples, the applicator 714 maycomprise a locking mechanism 720 to maintain the applicator 714 in acompressed state during engagement of the bandage 700, but in otherexamples, such as the applicator 730 in FIG. 48, the user will manuallymaintain the applicator 730 in a compressed state to align its hookregions 732 and 734 to the loop regions 702 and 704 to engage thebandage 700. A locking mechanism is not used. In some alternateapplication procedures, the applicator 714 (or 730) is not squeezed andinstead, one of the loop regions 702 and 704 of the bandage 700 is firstattached to a corresponding hook region 716 or 718, for example, andthen the bandage 700 may be stretched and the remaining loop region 702or 704 is attached to the applicator 714.

Although the examples in FIGS. 46A to 48 illustrate the loop regions 702and 704 on the bandage 700 and the hook regions 716 and 718 located onthe applicator 714, for example, in other variations, the relativerelationships between the hook and the loop attachment regions may bereversed. The hook-and-loop attachment regions may be provided on any ofthe variety of dressing applicators the variety of applicators describedherein. FIGS. 49A and 49B, for example, illustrate an applicator 750that is a variation of the applicator 220 depicted in FIGS. 12A and 12B,but with hook and loop regions 752 on the force members 754 instead ofthe plurality of projections. Applicator 220 is described in greaterdetail below.

In some variations, one or more flap regions 48 and 50 may be providedadjacent to the outer non-adhesive regions 36 and 38, or the applicatorattachment structures 40 and 42. Each of the flap regions 48 and 50 maybe located directly between an edge 10 and 12 of the treatment device 2and the outer non-adhesive regions 36 and 38 or applicator attachmentstructures 40 and 42. During use or preparation of the treatment device2 for application to the skin, the flap regions 48 and 50 may remainunstretched relative to the central non-adhesive region 18 and inneradhesive regions 20 and 22. Once the adhesive regions 20 and 22 areadhered to the skin, the flap regions 48 and 50, which may optionallyalso comprise an adhesive on their skin contacting surface, may beadhered to the skin. The flap regions may be adhered to the skin in anunstrained state, or in a strained state that is less than, equal to, orgreater than the strain in the central non-adhesive region 18 andadhesive regions 20 and 22. In still other variations, the flap regionsmay be cut or separated from the dressing after the dressing is applied.Perforations may be provided between the adhesive regions and the flapregions to facilitate separation.

The adhesive provided on the lower surface of the flap regions 48 and 50may be the same or may be different than the adhesive of the inneradhesive regions 20 and 22, including but not limited to thecomposition, thickness and/or distribution of the adhesive material. Insome variations, the adhesive of the flap regions 48 and 50 may have areduced T-peel release force and/or blunt probe tack force relative tothe adhesive provided for the inner regions 20 and 22. Various T-peelrelease force and/or blunt probe tack force ranges for the adhesive areprovided below. In some variations, the unstrained or less-strained flapregions may redistribute at least some of the strains acting on tissueabout the transition regions along the outer borders 32 and 34 of theinner adhesive regions 20 and 22. This may or may not reduce the risk ofskin stripping or blistering compared to devices without flap regions orwith flap regions of smaller width. In some variations, the actual widthof a section of the flap region or the average width of the flap regionor (or adhesive portion of the flap region) may be characterizedrelative to the corresponding width of the closest inner adhesive regionand/or the width of the closest outer non-adhesive region. The width ofthe flap region may be in the range of about 1 mm to about 10 cm ormore, sometimes about 5 mm to about 3 cm, and other times about 1 cm toabout 2 cm. The size of the flap region may be also characterizedrelative to the size of the other regions of the dressing. For example,in some variations, the width of the flap region may be at least about25%, about 33%, about 50%, about 75%, about 100%, or about 120% orhigher than the corresponding width of the closest inner adhesiveregion. The width of the flap region relative to the closest outernon-adhesive region may be at least about 50%, about 75%, about 100%,about 120% or higher.

The stretching of the adhesive regions when applied to the skin surfacemay result in an increased tissue density under the adhesive region.This may be the result of generally planar, tangential or parallelcompression of skin tissue that is directly attached to that adhesiveregion, resulting from the relaxation of the adhesive region. In someexamples, this tissue compression may reduce the risk of tissuestripping and/or blistering of skin in direct contact with the adhesive,in contrast to bandage “strapping” where one end of a bandage is adheredto the skin and then tensioned or pulled across a wound before the otherend is attached to the skin on the opposite side of the wound.

Furthermore, bandage “strapping”, while generating tension in thebandage during the application, may simultaneously generate a relativelyhigh tissue strain at the first adhesion site. This high tissue strainthen decreases when the bandage is attached to the skin at a secondadhesion site as the high peak stresses are redistributed along the skinunder the bandage. In contrast, when a pre-strained bandage is appliedto the skin, little if any strain may be transferred or generated in theskin as the adhesive regions are applied to the desired locations. Whenthe pre-strained bandage is permitted to relax, however, the strain (orpeak strain) in the skin may be increased. Thus, with a pre-strainedbandage, temporary high tissue strain may be avoided or otherwisereduced during the application procedure. In other variations, however,the device 2 may also be applied to the skin by strapping, or by acombination of pre-straining and strapping.

Although the depicted wound treatment device 2 may have a generallyrectangular configuration with a size of about 80 mm to about 40 mm, inother variations the device may have any of a variety of lengths andwidths, and may comprise any of a variety of other shapes. Also, thecorners of the device may be squared or rounded, for example. Thelengths and/or widths of the device may be in the range of about 5 mm toabout 1 meter or more, in some variations about 20 mm to about 500 mm,and in other variations about 30 mm to about 50 mm, and in still othervariations about 50 mm to about 100 mm. In some variations, the ratio ofthe maximum dimension of the wound device (e.g. its length) to anorthogonal dimension to the maximum dimension (e.g. width), excludingthe minimum dimension of the device (e.g. the thickness), may be in therange of about 1:1, about 2:1, about 3:1, about 4:1 about 5:1, about6:1, about 7:1, about 8:1, about 9:1 or about 10:1 or greater. In somevariations, the strain axis of the device in use may be oriented withrespect to the maximum dimension or to the orthogonal dimension to themaximum dimension.

The elastic material of the device may comprise a single layer ofmaterial or multiple layers of the same or different materials. Thematerial may have any of a variety of configurations, including a solid,foam, lattice, or woven configuration. The elastic material may be abiocompatible polymer, e.g., silicone. The thickness of polymer sheets,e.g., silicone polymer sheets or shape memory polymer sheets, may beselected to provide the devices or bandages with sufficient loadcarrying capacity to achieve desired recoverable strains, and to preventundesired amounts of creep deformation of the bandages or devices overtime. In some variations, the thickness across devices or bandages isnot uniform, e.g., the thickness across the device may be varied tochange the stiffness, the load carrying capacity, or recovery strains inselected orientations and/or locations. The elastic material may have athickness in the range of about 50 microns to 1 mm or more, about 100microns to about 500 microns, about 120 microns to about 300 microns, orin some variations about 200 microns to about 260 microns. In someexamples, devices having an edge thickness of about 500 microns or less,400 microns or less, or about 300 microns or less may exhibit less riskof skin separation from inadvertent lifting when inadvertently brushedagainst clothing or objects. In some variations, the devices or bandagesare tapered near the edges to reduce thickness. A tapered edge may alsoameliorate peak tensile forces acting on skin tissue adjacent to theadhesive edges of the wound treatment device. This may or may not reducethe risk of skin blistering or other tension-related skin trauma. Inother variations, the edges of the devices or bandage may be thickerthan the middle of the device or bandage. It is hypothesized that insome configurations, a thicker device or bandage edge may provide arelative inward shift of the location of the peak tensile forces actingnear the device or bandage edge, compared to devices or bandages ofuniform thickness.

The adhesive regions may comprise a pressure sensitive adhesive, e.g.,polyacrylate-based, polyisobutylene-based, silicone-based pressuresensitive adhesives, and the like. The T-peel release force and bluntprobe tack force of the adhesive may be measured by a standardized testmethod, such as ASTM D1876 and ASTMD2979 or other appropriate method. Insome variations, the T-peel release force or blunt probe tack test valueof the adhesive is configured to maintain loads of at least about 50mPa/mm for at least about 24 hours, about 48 hours, about 72 hours,about 1 week, about 2 weeks, about 3 weeks, about 4 weeks or more. Inother variations, the loads may be at least about 75 mPa/mm, about 100mPa/mm, about 125 mPa/mm, or at least about 150 mPa/mm over theparticular time period. The degree of adhesion (e.g. as measured by theT-peel release force or blunt probe tack test value) may vary dependingupon the degree of strain placed onto the skin or incision site, and insome variations, these time periods may be based upon an average skinstrain of about 10%, about 20%, about 30%, about 40%, or about 50% ormore. In some variations, the adhesive may have a T-peel release forceof at least about 150 kg/m, about 160 kg/m, about 170 kg/m, about 180kg/m, about 190 kg/m, about 200 kg/m, about 210 kg/m, about 220 kg/m,about 230 kg/m, about 240 kg/m, about 250 kg/m, about 260 kg/m, about270 kg/m, about 280 kg/m, about 290 kg/m, about 300 kg/m, about 310kg/m, about 320 kg/m, about 330 kg/m, about 340 kg/m, about 350 kg/m,about 400 kg/m, about 450 kg/m, or at least about 500 kg/m or higher. Insome further variations, the T-peel release force may be no greater thanabout 1000 kg/m, about 900 kg/m, about 800 kg/m, about 700 kg/m, about600 kg/m, about 500 kg/m, about 400 kg/m or about 300 kg/m. The bluntprobe tack test value of the adhesive may be at least about 0.50 kg,about 0.55 kg, about 0.60 kg, about 0.65 kg, about 0.70 kg or about 0.75kg or higher, and may be no greater than about 1 kg, about 0.9 kg, about0.8 kg, about 0.7 kg, or about 0.6 kg. The T-peel release force andblunt probe tack force may be measured by a standardized test method,such as ASTM D1876 and ASTMD2979 or other appropriate method. Otherfeatures or variations of the device are described in U.S. applicationSer. No. 11/888,978, filed on Aug. 3, 2007, which was previouslyincorporated by reference.

In some variations, the final compressive stress and strain imposed ontothe skin by the elastic material 4 may be the result of the dynamicequilibrium between the tensile stress in the skin and the elasticmaterial 4 of the wound treatment device 2. Referring to FIGS. 13A to13D, the skin at incision site 90 typically comprises an inherenttension 96 a that stretches incision site 90, whether or not any tissuewas excised from the incision site 90. The elastic material 4 and theadhesive region 18 may be configured to be applied to a skin location sothat when the device 2 is stretched to a particular tension 94 a andthen adhered to the incision site 90, tensile stress in the device 2 istransferred to the incision site 90 to compress the tissue directlyunder the device 2 along a tangential axis 98 to the skin surface 99,the stress and strain imposed onto the skin location has a net orresultant orientation or axis is also generally tangential or planar tothe elastic material 4 and/or the outer surface of the skin location,with a similar axis to the orientation or axis of the tensile stress inthe device 2. The tension 94 a in the device 2 will relax to a tensionlevel 94 b that maintains equilibrium with increased tension 96 b in theskin adjacent to the device 2. The application of the device 2 to theskin location may involve the placement of the device 2 withoutoverlapping or being wrapped onto itself, e.g. wherein only adjacentregions of the device 2 are interconnected and wherein non-adjacentregions of the device 2 are not interconnected. The actual amount ofstress and strain imposed on the skin may vary, depending upon theparticular person, skin location, the thickness or various mechanicalcharacteristics of the skin layers (e.g. epidermis, dermis, orunderlying connective tissues), and/or the degree of pre-existingscarring, for example. In some further variations, the wound treatmentdevice 2 may be selected or configured for use at a specific bodylocation, such as the scalp, forehead, cheek, neck, upper back, lowerback, abdominal region, upper torso (including but not limited to thebreast folds), shoulder, upper arm, lower arm, palm regions, the dorsumof the hand, finger, thigh, lower leg, the dorsum or plantar surface ofthe foot, and/or toe. Where applicable, some body regions may be furtherdelineated into anterior, posterior, medial, lateral, proximal and/ordistal regions, e.g. the arms and legs.

The wound treatment device 2 may be configured to impose a skin strainin the range of about 10% to about 60% or more, in other configurationsabout 15% to about 50%, and in still other configurations, about 20% toabout 30% or about 40%. To achieve the desired degree of skin strain,the wound treatment device 2 may be configured to undergo elastictensile strain in the range of about 20% to about 80% or more, sometimesabout 30% to about 60%, and other times about 40% to about 50% or about60%. The device 2 may comprise any of a variety of elastic materials,including but not limited to silicones, styrenic block copolymers,natural rubbers, fluoroelastomers, perfluoroelastomers, polyether blockamides, thermoplastic elastomers, thermoplastic polyurethane,polyisoprene, polybutadiene, and the like. The material may have a ShoreA durometer in the range of about 20 to about 90, about 30 to about 80,about 50 to about 80. One example of the elastic material 4 is MED82-5010-05 by NUSIL TECHNOLOGY LLC (Carpinteria, Calif.). Other examplesof suitable materials are described in U.S. application Ser. No.11/888,978, which was previously incorporated by reference in itsentirety.

When the strained device 2 is applied to a skin location and allowed toat least partially recover to its base configuration, the recovery levelor equilibrium level of strain in the device may be in the range ofabout 10% to about 60% or more, in other configurations about 15% toabout 50%, and in still other configurations, about 20% to about 30% orabout 40%. The ratio between the initial engineering tensile strainplaced onto the device 2 before recovery and the resulting engineeringcompressive strain in the skin may vary depending upon the skin type andlocation, but in some examples, may be about 2:1. In other examples, theratio may be in the range of about 4:1 to about 5:4, about 3:1 to about5:3, or about 5:2 to about 2:1. These skin strain characteristics may bedetermined with respect to a reference position of the body or bodypart, e.g. anatomical position, to facilitate reproducible measurements.The particular degree of strain may be characterized as either anengineering strain or a true strain, but may or may not be calculatedbased upon or converted from the other type of strain (e.g. the strainmay be based upon a 60% engineering strain that is converted to a truestrain).

In some further variations, one or more characteristics of the elasticmaterial 4 may correspond to various features on the stress/strain curveof the material 4. In FIGS. 21A and 21B, for example, the engineeringand true stress/strain curves 400 and 402, respectively, for onespecific example of the wound treatment device (GLYDe-M) is depicted. Asillustrated in FIG. 21A, the device comprises a material that exhibitsan engineering stress 404 of about 1.2 MPa at about 60% engineeringstrain, but in other examples, the engineering stress may be in therange of about 900 KPa to about 2.5 MPa, about 1 MPa to about 2.2 MPa,about 1 MPa to about 2 MPa, about 1.1 MPa to about 1.8 MPa, about 1.1MPa to about 1.5 MPa, about 1.2 MPa to about 1.4 MPa. When unloading orrelieving stress from the device 2, the material 4 may be configuredwith an engineering stress of about 380 KPa at about 40% engineeringstrain 406, but in other examples, the engineering stress duringunloading of the material 4 to about a 40% strain may be in the range ofabout 300 KPa to about 700 KPa, about 325 KPa to about 600 KPa, about350 KPa to about 500 KPa, or about 375 KPA to about 425 KPa. Whenunloading the material 4 to an engineering strain 408 of about 30%, thematerial exhibits an engineering stress of about 300 KPa, but in otherexamples, the engineering stress when unloading the material 4 to about30% strain may be in the range of about 250 KPa to about 500 KPa, about275 KPa to about 450 KPa, about 300 KPa to about 400 KPa, or about 325KPA to about 375 KPa. When unloading to an engineering strain 410 ofabout 20%, the material may have an engineering stress of about 100 KPa,but in other examples, the unloading engineering stress at about 20% maybe in the range of about 50 KPa to about 200 KPa, about 75 KPa to about150 KPa, or about 100 KPa to about 125 KPa. In some examples, thematerial 4 may be configured to at least achieve a specific range orlevel of engineering stress at each of the specified engineering strainlevels described above, but in other examples, the material 4 may beconfigured for lower levels of maximum engineering strain, e.g. up toabout 30% or about 40%.

In some examples, certain portions of the stress/strain curve may have aparticular morphology. For example, for a particular level of maximumstrain the loading curve may be generally linear on the correspondingtrue stress/strain curve. As illustrated in FIG. 21B, up to a truestrain 412 of about 45%, the loading curve 414 has a generally linearconfiguration. In other examples, the configuration may only be linearalong a portion of the loading curve or may be curved along the entireloading curve. Where the loading curve is non-linear, the loading curvemay be convex, concave or both. Also, in some examples, the tangent line416 of the loading curve 414 (i.e. the line between the two triangles)may also be generally co-linear.

In some variations, the elastic material 4 comprises a material havingan elastic modulus E of at least about 1 MPa, about 1.5 MPa, about 2MPa, about 2.5 MPa, about 3 MPa, about 3.5 MPa, about 4 MPa, about 5MPa, about 6 MPa, about 7 MPa, about 8 MPa, about 9 MPa or at leastabout 10 MPa or greater. The material elastic modulus E may be nogreater than about 10 MPa, about 9 MPa, about 8 MPA, about 7 MPa, about6 MPa, or about 5 MPa, or about 4 MPa.

In addition to the absolute stress levels at certain strain levelsdescribed above, the material may also be characterized with respect tothe ratio between a) the stress to achieve a particular strain duringloading, and b) the stress at the same strain during unloading. Forexample, the material may have a ratio of at least 4:1 to about 3:2 ateach of the 20%, 30% and 40% strain levels, but in other examples, thematerial may exhibit these ratios only at 20%, at 30%, or at 40% strainlevels, or at both 20% and 30% but not 40%, or at both 30% and 40% butnot 20%. In other examples, the ratio at one, some or all of the strainlevels may be in the range of about 3:1 to about 2:1, or about 5:2 toabout 2:1.

In some examples, the elastic material of the device 2 may be configuredunder testing conditions to achieve a stable level of stress at aconstant strain, e.g. the material exhibits a limited amount of stressrelaxation over a particular period of time and at a particular level ofstrain. The period of time may be at least about 8 hours, about 12hours, about 18 hours, about 24 hours, about 36 hours, about 48 hours,about 72 hours, about 4 days, about 5 days, about 6 days, or about aweek or more. The level of strain may be about 10%, about 20%, about30%, about 40%, about 50%, about 60%, about 70%, or about 80% or more.FIGS. 32A and 32B illustrate the stress of the GLYDe-M device overvarious time curves 418 and 420, respectively. Specifically in FIG. 32B,the GLYDe-M device is configured to maintain an engineering stress ofabout 300 KPa at an engineering strain of about 30% without noticeabledeviation over a period of about 1 hour, about 2 hours, about 3 hours,about 4 hours, about 5 hours, about 6 hours, about 7 hours, or about 8hours or more. The stresses at 10% strain, 20% strain, and at 40% may belower or higher. A comparator line 422 is provided to illustrate thestrain level between the two curves 418 and 420.

In some variations, the elastic material or the device may be configuredunder testing conditions to maintain a particular minimum level ofstress when held at a constant strain over a particular time period. Toassess the ability of a backing material to maintain a stress and strainon skin over time, engineering strains were measured while each backingmaterial was tensile strained to 60% at a rate of 100 microns per secondand held for 10 minutes, and then dropped to a strain of 30% at a rateof 100 microns per second and held for 9 hours. In FIGS. 32A and 32B,for example, the GLYDe-M device is able to maintain an engineeringstress level of about 350 KPa at an engineering strain of 30%. In someother examples, the minimum level of stress may be about 100 KPa, about120 KPa, about 140 KPa, about 160 KPa, about 180 KPa, about 200 KPa,about 220 KPa, about 240 KPa, about 260 KPa, about 280 KPa, about 300KPa, about 320 KPa, about 340 KPa, about 360 KPa, about 380 KPa, about400 KPa, about 420 KPa, about 440 KPa, about 460 KPa, about 480 KPa,about 500 KPa, about 600 KPa, about 700 KPa, about 800 KPa, about 900KPa or about 1000 KPa or greater. The level of constant strain may bedifferent in other configuration, with a level of about 15%, about 20%,about 25%, about 30%, about 35%, about 40%, about 45%, about 50%, about55%, about 60%, about 65%, about 70%, about 75%, or about 80%. The timeperiod over which the device is able to maintain a stress level may beat least about 2000 seconds, about 3000 seconds, about 4000 seconds,about 5000 seconds, about 6000 seconds, about 7000 seconds, about 8000seconds, about 9000 seconds, about 10000 seconds, about 20000 seconds,about 30000 seconds, about 40000 seconds, about 50000 seconds, about60000 seconds, about 70000 seconds, about 24 hours, about 36 hours,about 48 hours, about 72 hours, about 4 days, about 5 days, about 6days, about 7 days, about 10 days, about 2 weeks, about 1 month or more.In some variations, the device 2, the elastic material 4 and/or theadhesive material is configured to exhibit less than about a 15% changein stress or strain level over the particular period when applied to askin surface or test surface. In other examples, the degree of changemay be about 12%, about 10%, about 8%, about 6%, about 5%, about 4%,about 3%, or about 2% or less. The stress or strain may be anengineering stress or strain, and/or a true stress or strain.

Materials Testing

A variety of commercially available bandages were evaluated along withone specific example of a wound treatment device (GLYDe-M) to assessvarious force loading and recovery properties. Where the commerciallyavailable bandage comprised a backing material along with an absorbentpad, the bandage was tested both as an intact bandage, and also with theabsorbent pad carefully removed to isolate the properties of the backingmaterial. The following commercially available bandages were testedalong with the GLYDe-M system:

TABLE 1 Product Thickness Manufacturer Product (backing only)* — Woundtreatment device (GLYDe-M) 0.26 mm 3M (St. Paul, MN) Steri-Strip ™(regular) 0.15 mm 3M (St. Paul, MN) Steri-Strip ™ (elastic) 0.27 mmCVS/Pharmacy ® Self-Adherent Wrap (generic)   1 mm J&J (New Brunswick,NJ) BAND-AID ® Flexible Fabric 0.32 mm J&J (New Brunswick, NJ)BAND-AID ® Tough Strip 0.18 mm J&J (New Brunswick, NJ) BAND-AID ® UltraStrip 0.23 mm 3M Nexcare ™ (St. Paul, MN) Tegaderm ™ 0.05 mm ConvaTec(Skillman, NJ) DuoDERM ® Extra Thin 0.49 mm ConvaTec (Skillman, NJ)DuoDERM ® CGF ®   2 mm CVS/Pharmacy ® Elastic Bandage (generic) 0.88 mmCVS/Pharmacy ® Silicone Scar Sheet (generic) 0.64 mm *and adhesive, ifany.

The above bandages underwent testing to assess their material propertieswith respect to their stress-strain curves. Each of the bandages wastensile strained to an engineering strain of 60% and then permitted torecover. To simulate conditions at least somewhat similar to use onhuman skin, the testing was performed at a temperature of 33 degreesCelsius and at a humidity of 50%. In some examples, use of elevatedtemperatures and/or humidity may better reflect real-world performanceof the device or bandage when applied to a person. The measurements ofthe engineering stress and engineering strain were also calculated astrue stress/strain curves and were also used to calculate the initialelastic modulus of the material.

Referring to FIGS. 14A and 14B, the stress-strain curves for a regularSteri-Strip™ demonstrated that the material failed to strain to 60%. Asshown in the curve 500 in FIG. 14A, the Steri-Strip™ resulted in rupture502 before reaching an engineering strain of 35%. Other evidence ofstructural failure included the downsloping, irregular segments 504along the loading portion of the curve 500. Furthermore, substantiallevels of engineering stresses of almost 15 MPa were needed to achievean engineering strain of only about 5%. In some variations, use of highstresses to strain the wound treatment device may pose a safety risk tothe user and/or the patient. Although the force used to strain a devicewill vary based upon the elastic modulus, thickness and width of thedevice, in some variations, the elastic modulus of the material used inthe wound treatment device may be in the range of about 1 MPa to about10 MPa, in some variations about 2 MPa to about 8 MPa, in othervariations about 3 MPa to about 5 MPa, and in still other variations inthe range of about 3 MPa to about 4 MPa. In some instances, a higherelastic modulus may generate a greater risk of skin blistering.

Referring to FIGS. 15A and 15B, some backing materials, such as theflexible fabric used in Flexible Fabric BAND-AIDS®, are unable to imposesubstantial loads onto the skin when the backing material is strainedand then permitted to recover the strain. As shown in the curve 510 inFIG. 15A, although the flexible fabric of this BAND-AID® was able toreach an engineering strain of 60%, upon unloading, engineering strains512 fell quickly, and upon recovery to strains of 30% and 20%,respectively, the flexible fabric material was unable transfersignificant forces 514 and 516, respectively, to the skin. Thissubstantial difference may or may not reflect damage to the underlyingmaterial. As shown in FIGS. 16A and 16B, an intact Flexible FabricBAND-AID® also had a stress-strain curve 520 with a recovery portion ofthe 522 in FIG. 16A showing substantial drop-off and limited residualforce at strains 524 and 526 at 30% and 20%, respectively.

Another example of a material that failed to elastically strain to 60%is the backing material of Tough Strip™ BAND-AID®. As depicted in theengineering stress-strain curve 530 in FIG. 17A, structural damage isdemonstrated by the downsloping, irregular segment 532 of the curve 530during loading, with the peak engineering stress 534 occurring at about40% strain rather than 60% strain. Relative to the peak engineeringstress 534, or the corresponding loading stresses 536 and 538 at 20% and30%, the recovery stresses 540 and 542 at 20% and 30% also illustratethat this material may be inefficient at transferring loads to the skin.As further depicted in FIGS. 18A and 18B, the stress-strain curves of anintact Tough Strip™ BAND-AID® continue to show evidence of structuraldamage at even earlier levels of strain.

Although the stress-strain curves depicted herein reflect certainintrinsic properties of the materials used in the tested bandages, thestress-strain curves alone may not be indicative of the suitability of aparticular bandage to impose a strain on a skin location. The amount ofstress and strain imposed on the skin may also vary depending upon thethickness, width, length, elastic modulus, and other materialcharacteristics of the wound treatment device, as well as the amount ofstress and strain placed on the wound treatment device. The force Fexerted by the device may be generally characterized by the followingequation, where E is the elastic modulus of the elastic material 4, A0is cross-sectional area of the elastic material 4 transverse to thedirection of stress, L0 is the initial length of the elastic materialalong the direction of stress and ΔL is the change in the length:F=E·A ₀ ·ΔL/L ₀

This force may also be characterized in terms of the force per width ofthe elastic material 4:

$\frac{F}{mm} = {\frac{E\; A_{0}\Delta\; L}{\left( L_{0} \right)({mm})} = \frac{{E \cdot {thickness}_{0} \cdot \Delta}\; L}{L_{0}}}$

In one example depicted in FIGS. 19A and 19B, the stress-strain curves550 and 552 for Nexcare™ Tegaderm™ occlusive bandages are provided.Although these curves do not indicate evidence of damage or rupture whenloaded to 60% engineering strain 554 (or corresponding true strain 556),as did the Steri-Strip™, Flexible Fabric BAND-AID® and Tough Strip™BAND-AID®, when the bandages are characterized in terms of theirload-carrying capacity, as shown in FIG. 30C, Tegaderm™ exhibitedsubstantially lower loads per millimeter width than many other testedbandages. Thus, the ability of some bandages to impose a stress onto theskin to generate skin strain may be limited. Also, as explained ingreater detail below, many elastic materials was unable to sustainconsistent levels of stress over time. This may be the result of stressrelaxation in the backing material which was not intended to be strainedto 30% as tested.

The stress-strain curves of still other bandages are provided in FIGS.22A to 29B and 41A and 41B. FIGS. 22A and 22B illustrate engineering andtrue stress/strain plots 570 and 572, respectively, of elasticSteri-Strip™ material. Many of these bandages comprise materials withstress-strain curves that involve lower levels of stress, that result inlower load carrying capacity, as shown in FIG. 30C, while other bandagescomprise materials that exhibit significant stress relaxation or otherdecreased in the strain imposed on the skin over time. As shown in FIG.31A, the Nexcare™ Tegaderm™ backing material initially generated anengineering stress 560 of about 750 KPa when dropped to a strain of 30%,but over the course of 9 hours, the level engineering stress 562continued to decrease, as shown in FIG. 31B with comparator line 564. Insome examples, the backing material may be configured so that theengineering stress is tested at an engineering strain of 30% or someother level of strain over a period of time, the engineering stresslevels decreases by less than about 15%, about 10%, about 8%, about 6%,about 5%, about 4%, about 3%, about 2%, or about 1% or less, or eveneffectively 0% for a particular time period.

The other backing materials tested generated an engineering stress ofabout 200 KPa or less at an engineering strain of 30% and/ordemonstrated a decrease in the engineering stress over 9 hours, asdepicted in FIGS. 34A to 40B. In some variations, this may indicate thatthe particular bandage may not be configured to generate consistentforces sufficient to impose sufficient stresses onto the skin todecrease skin tension, including high skin tension regions of the bodysuch as the back and face.

For example, as shown in FIGS. 33A to 34B, both the elastic Steri-Strip™and the BAND-AID® ULTRA STRIP® generated an initial engineering strainof around 200 KPa at 30% strain, but also demonstrated at least somedecrease in stress over time, with the ULTRA STRIP® decreasing more thanthe elastic Steri-Strip™. These decreases may be even greater if testedover longer periods of time, such as about 12 hours, about 24 hours,about 36 hours, about 48 hours, about 72 hours, about 96 hours, about 1week, about 2 weeks, about 3 weeks, or about 4 weeks or greater, forexample. As shown in FIGS. 35A to 40B, the backing materials of theother bandages generated substantially less than 200 KPa engineeringstress, and some materials such as the DuoDERM® CGF®, the CVS/Pharmacy®elastic bandage, and the self-gripping CVS/Pharmacy® self-adherentgentle wrap, generated less than 50 KPa. Even at these lower levels ofstress, however, some of the backing materials were unable to sustainconsistent engineering stress levels over 9 hours, such as shown inFIGS. 37B, 38B, and 39B for DuoDERM® Extra Thin, DuoDERM® CGF® andCVS/Pharmacy® elastic bandage, respectively. Of further note is that thetwo bandages configured to be stretched when applied to the body, theCVS/Pharmacy® elastic bandage and the CVS/Pharmacy® self-adherent gentlewrap, are both designed to be wrapped circumferentially around a bodypart and to be attached back onto itself, exhibited the lowestengineering stresses when strained to 30%. This is also illustrated inFIG. 30C, where the portions of the unloading curves at 30% true strainare the lowest among the tested bandages, and at 20% true strain, areamong the lowest along with DuoDERM® Extra Thin.

In addition to testing of the mechanical properties of the backingmaterials, the adhesive properties of the commercial bandages were alsoassessed. The testing was performed only with the bandages that had atleast some adhesiveness or tackiness that permits measurement ofslippage when applied to a test surface, excluding the CVS/Pharmacy®self-adherent gentle wrap and the CVS/Pharmacy® elastic bandage. Also,bandages that could not be elastically strained to 20% engineeringstrain, such as a regular Steri-Strip™ and the BAND-AID® Tough Strip,were excluded. To test the remaining materials, the backing material ofeach bandage was trimmed to a sample size of approximately 12 mm×50 mm.Each sample was stretched to either an engineering strain of 20% or 40%and then applied to polycarbonate sheeting and the degree of slippagewas observed up to 48 hours. Although the intrinsic properties of eachadhesive used with each bandage may not be directly comparable based onthis testing due to substantial differences in engineering stressgenerated at the specified levels of strain, and/or the degree of stressrelaxation exhibited by each material, such testing may provide at leastsome indication of existing bandages to impose stresses onto skin.

TABLE 2 Slippage at Slippage at Manufacturer Product 20% Strain 40%Strain — Wound treatment device None @ None @ (GLYDe-M) 48 hrs. 48 hrs.3M (St. Paul, MN) Steri-Strip ™ (elastic) None @ None @ 22 hrs. 22 hrs.J&J BAND-AID ® Flexible None @ Slight @ 24 hrs (New Brunswick, NJ)Fabric 46 hrs. Evident @ 46 hrs J&J BAND-AID ® Ultra Strip Slight @ 24hrs Evident @ 2 hrs 40 min (New Brunswick, NJ) 3M Nexcare ™ Tegaderm ™None @ None @ (St. Paul, MN) 24 hrs. 24 hrs. ConvaTec DuoDERM ® ExtraThin Slippage @ Slippage @ (Skillman, NJ) 22 hrs. 22 hrs. ConvaTecDuoDERM ® CGF ® Edge peel @ 3 hrs Slippage @ 3 hrs (Skillman, NJ)Slippage at 24 hrs More Slippage @ 24 hrs CVS/Pharmacy ® Silicone ScarSheet Slippage @ 3 min Slippage @ 3 min

As mentioned previously, although the actual force required to tensilestrain a device may vary, depending upon the size of the device, in somevariations, the device may be configured to achieve an engineeringstrain of about 60% using a load per millimeter width that is less thanor equal to about 6 Newtons/millimeter (N/mm), about 5 N/mm, about 4N/mm, about 3 N/mm, about 2 N/mm, about 1.1 N/mm, about 0.8 N/mm, about0.7 N/mm, about 0.6 N/mm, about 0.5 N/mm.

Each of the material or structural characteristics above may be mixedand matched to achieve the desired tensile stress/strain profile. In onespecific example, the elastic material 4 may have an elastic modulus Ein the range of about 2 MPa to about 4 MPa, exhibits a generally linearor curvilinear stress/strain loading curve (either engineering stressσ/strain e or true stress σtrue/strain ε) with elastic deformation up toat least about 60% tensile engineering strain. In other examples, theelastic deformation property may be limited to about 20%, about 30%,about 40%, or about 50%. The elastic material 4 may also be configuredwith an average thickness in the range of about 100 microns to about 500microns, about 200 microns to about 400 microns, or about 200 microns toabout 300 microns. The elastic material 4 may also be configured toexert a minimum load per millimeter width at a particular strain. Forexample, when tensile strained to an engineering strain of 60%, theelastic material 4 may exert a compressive load/mm of at least about0.3N, about 0.35N, about 0.4N, about 0.45N, or at least about 0.5N. Insome examples, when tensile strained to an engineering strain of 40%,the elastic material 4 may exert a compressive load/mm of at least about1.5 N/mm, about 1.6 N/mm, about 1.7 N/mm, about 1.8 N/mm, about 1.9N/mm, about 2 N/mm, about 2.1 N/mm, about 2.2 N/mm or about 2.3 N/mm,about 2.4 N/mm, about 2.5 N/mm or about 3 N/mm or greater. In stillother examples, when tensile strained to an engineering strain of 30%,the elastic material 4 may exert a compressive load/mm of at least about0.7 N/mm, about 0.8 N/mm, about 0.9 N/mm, about 1 N/mm, about 1.1 N/mm,about 1.2 N/mm, or about 1.3 N/mm or greater. In yet other examples,when tensile strained to an engineering strain of 20%, the elasticmaterial 4 may exert a compressive load/mm of at least about 0.4 N/mm,about 0.45 N/mm, about 0.5 N/mm, about 0.55 N/mm, about 0.6 N/mm, about0.65 N/mm, or about 0.7 N/mm or greater. On stress measurements at anengineering strain of about 30%, over a period of at least about 8hours, about 12 hours, about 24 hours, or about 72 hours, theengineering strain may be at least about 175 KPa, about 200 KPa or about225 KPa with a decrease in engineering strain that is no greater thanabout 12%, about 10%, about 8%, about 6%, about 5%, about 4%, about 3%,about 2% or less than about 1%.

Release Liner

Referring to FIGS. 2A and 2B, the wound treatment device 2 may beprovided with one or more release liners 52, 54 and 56 to protect one ormore of the adhesive regions 20, 22, 48 and 50. The release liners 52,54 and 56 may be configured with one or more flaps or tabs 58, 60, 62,64, 66 and 68 that project from the edges 10, 12 or surfaces 6, 8 of thetreatment device 2 to facilitate grasping or removal of the releaseliners 52, 54 and 56. FIG. 2C depicts the liners 52, 54 and 56 withoutthe wound treatment device 2. In some examples, the release liners mayresist inadvertent adhesion of the wound treatment device to itself orother surfaces during loading of the device onto an applicator, orduring application of the device to the skin. In variations where thedevice has multiple separate adhesive regions, separate release linersmay be provided for each region, or some regions may be covered by thesame release liner. Referring back to FIGS. 2A and 2B, the three releaseliners 52, 54 and 56 are provided to cover the four adhesive regions 20,22, 48 and 50, with two end release liners 52 and 54 covering the flapregions 48 and 50, respectively and a single release liner 56 coveringboth inner adhesive regions 20, 22. The end release liners 52 and 54each comprise two tabs 58 and 60 which project from the same edge 10 and12, respectively, of the device, but in other variations, one or moretabs may project from the other edges 14 and/or 16, from multiple edges,or from no edges. The central release liner 56, for example, comprisestabs 66 and 68 that project from opposing edges 10 and 12 of the device.Although the tabs 58, 60, 62 and 64 are depicted as aligned with theedges 14 and 16 of the treatment device 2, in other variations theliners may be configured with tabs at other locations, or with adifferent number of tabs. In some variations, the tabs may also befolded or creased, which may facilitate grasping where the tabs arelocated against a surface rather than projecting from an edge.

In variations comprising multiple release liners, the liners may or maynot be removed at different times or in a particular order. In somevariations the liners may include indicia to facilitate removal in aparticular order. The indicia may comprise alpha-numeric characters 70and 72, color, graphic symbols and the like, and may be located on thebody of the liner or on the tabs, if any. In FIGS. 2A and 2B, forexample, users may be instructed to remove the central liner 56 duringthe loading of the treatment device 2 onto an applicator and/or forapplication to a skin site. After the initial adherence of the treatmentdevice 2 to the skin, the outer release liners 52 and 54 covering theflap regions 48 and 50 may then be removed to permit adherence of therest of the treatment device 2.

The release liners may comprise any of a variety of materials, includingboth opaque and transparent materials. The release liners may compriseMylar or paper, or any other material with reduced adhesion to theadhesive material(s) of the device. In some examples, the central liner56 (or a different liner) may be reapplied to the inner adhesive regions20 and 22 after the treatment device 2 is loaded onto an applicator,which may protect the adhesive materials until actual application to theskin. The liners may comprise different surface geometries, e.g. surfaceroughness, and/or indicia that may permit identification of the originalliner surface that was applied to the adhesive regions, which may reducedegradation of the adhesive regions from dust, dander and/or othersubstances if the incorrect side of the liner is reapplied to thedevice.

Applicator

As noted previously, an applicator, tensioning device and/or strainingdevice may be provided in some embodiments to impart a strain to a skintreatment device with an external force and/or to maintain a strainimparted to the skin treatment device. In some examples, the strainingdevice may be configured to impart and/or maintain a singlepredetermined or pre-set strain or a plurality of predetermined orpre-set strains. Features described herein with respect to an applicatormay also be used in any tensioning or straining device that is used tostrain a skin treatment device. An applicator, tensioning or strainingdevice that is described as being in an unstrained configuration is in aconfiguration in which a skin treatment device may be unstrained orrelatively less strained when attached to the applicator, tensioning orstraining device. An applicator, tensioning, or straining device that isdescribed herein has being in a strained configuration is in aconfiguration in which a skin treatment device may be strained orrelatively more strained when attached to the applicator, tensioning orstraining device. Features described herein with respect to anapplicator may also be used in any tensioning or straining device thatis used to strain a skin treatment device.

A skin treatment device that is described herein is a device that may beapplied, attached to or coupled to one or more layers of the skin of asubject and may include without be limited to, a wound treatment device,a dressing, bandage, or other device.

Attachment structures of an applicator, tensioning or straining devicemay include any structures that are used to attach or couple anapplicator, tension or straining device to a skin treatment device. Suchdevices may include but are not limited to pockets and tabs, hook andloop mechanism, hooks, angled bars, adhesives, removable adhesives,pegs, rip cords, towel bar configurations, sliding pins, friction locks,cam locks, vacuum or suction devices, snap connectors, carpet tack,press fit connections or other connections.

The attachment structure profile may be straight, curved or otherwisevaried. For example, the shape of the attachment structures may beconfigured to follow the shape of the area of the subject's body towhich the skin treatment device is to be attached. A tensioning deviceor applicator may be selected or configured to have a profile that has adesirable profile for a particular body location or profile where theskin treatment device is to be placed on a subject's skin. A tensioningdevice or applicator may be selected or configured to closely match aportion of a subject's body profile. The attachment structures may becurved, curvable, bendable, deformable, shapeable or movable to providealternative shapes or profiles of an attached skin treatment device.

Attachment features or structures of a skin treatment device may includeany of the attachment structures or corresponding structures to theattachment structures.

Attachment structures and corresponding attachment features may beconfigured to provide multi direction strain or additional strain in anorthogonal direction.

In some variations the applicator may comprise a mechanism configured tofacilitate separation, release, removal or detachment of the attachmentstructures of the applicator from the attachment features of the skintreatment device, including but not limited to the separation devicesand methods described herein. Releasing mechanisms may include but arenot limited to pivoting, rolling, rocking or sliding features associatedwith or coupled to attachment structures of the applicator. They may beself-releasing latches or spring members. They may be actuated when apressure member is applied to a skin treatment device prior to removingthe applicator. They may be manually actuated. The mechanisms mayinclude levers, latches, locking members, spring members, for example.

A variety of locking, latching or detent mechanisms may be used tomaintain the applicator in a various configurations including but notlimited to unstrained, partially strained, strained, unstamped, orstamped configurations. A variety of locking, latching or detentmechanisms may be used to maintain a skin treatment device in a varietyof configurations including unstrained, partially strained, strained. Bylocking an applicator in a strained position a predetermined strain of agiven skin treatment device may be achieved. Other locking mechanisms,including but not limited to other locking mechanisms described hereinmay be used. A variable locking mechanism may be used to vary the amountof strain for a given skin treatment device. Such mechanisms may bereleasable to permit straining, stamping, release of the attachmentstructures from the skin treatment device, or to release variousstructures to permit reloading of the device.

An actuator, actuation force may be used or applied at any point duringstraining of a skin treatment device and is externally applied to theapplicator, either manually or otherwise. Optionally, an actuator orhandle may be provided that provides a mechanical advantage greater than1 at least at some point when actuated. Optionally a mechanicaladvantage may increase as a device is strained.

Applicators configured with any of a variety of force transfermechanisms may be used to transfer forces exerted onto the applicator tothe skin treatment device, including but not limited to leaf springs,helical springs, pneumatic or hydraulic struts, sliders, helicallythreaded shafts, articulated linkages, pivoting levers, and the like.The force transfer mechanisms may be configured to transfer theresulting force onto the skin treatment device along the same directionas the originally exerted force, or in other configurations along adifferent direction. For example, the applicator 220 in FIG. 12Atransfers force along the same direction as originally exerted by theuser, while the applicator 1000 in FIG. 51A transfers the rotary forceexerted by the user into a linear spreading force, and the applicator1100 in FIG. 53A transfers a force that is perpendicular to the userexerted force. Also, while some force mechanisms provide the user with amechanical advantage when straining a skin treatment device, e.g.applicator 1100 in FIG. 53A, others may not, e.g. applicator 200 in FIG.6. These and other examples of applicators and force mechanisms aredescribed in greater detail below.

Applicators described herein may provide accessible areas or spaces toaccess areas where the skin treatment device is applied to the skin sothat the adhesive may be pressed on to the skin. The adhesive used maybe, for example, a pressure activated adhesive (PSA), as a silicone,acrylic, styrene block copolymer, vinyl ether, nitrile or other PSA. Inother variations, a non-pressure sensitive adhesive may be used,including but not limited a heat or light-cured adhesive.

In some variations, the applicator may comprise an attachmentconfiguration that facilitates attachment of a device to the applicator,and a delivery configuration that stretches or strains the attacheddevice by about 20%, about 30%, about 40%, about 50%, about 60%, about70%, about 80%, about 90%, about 100%, or about 110% or more, relativeto its unstretched or unstrained configuration. The applicator may havea greater strain in the attachment configuration than in the deliveryconfiguration. The applicator may be configured such that the strain itimposes generally falls within with a one or two-sided tolerance ofabout 2%, about 3%, about 4%, about 5%, about 6%, about 7%, about 8%,about 9%, about 10%, about 15%, or about 20%, for example. The load perwidth imposed by the applicator onto the treatment device along its axisof tensile strain may vary, depending upon the amount of desired strainand the material characteristics of the device. For example, theapplicator may be configured to exert a engineering strain of about 60%to the device using a load per millimeter width that is in the range ofabout 0.1N to about 1N, about 0.2N to about 0.8N, about 0.3N to about0.6N, or sometimes in the range of about 0.4N to about 0.5N or 0.6N. Inanother example, the applicator may be configured to exert a strain ofabout 40% to the device using a load per millimeter width that is in therange of about 0.05N to about 0.6N, about 0.1N to about 0.5N, about 0.2Nto about 0.4N, or about 0.3N to about 0.4N. In still another example,the applicator may be configured to exert a strain of about 30% to thedevice using a load per millimeter width that is in the range of about0.05N to about 0.5N, about 0.1N to about 0.3N, or about 0.2N to about0.3N.

The applicator may also be characterized by the force required tocompressively strain the applicator to a particular strain level, and/orby the force the applicator exerts when the applicator is compressed toa particular strain level. For example, the applicator may be configuredto be compressively strained to about 40% using a load per millimeterwidth (or dimension transverse to the direction of strain) that may beat least about 0.1N, about 0.2N, about 0.3N, about 0.4N, about 0.5N,about 0.6N, about 0.7N, or about 0.8N or greater. In other examples, theapplicator may be configured to be compressively strain to about 20%using a load per millimeter width (or transverse dimension) that is atleast about 0.05N, about 0.1N, about 0.2N, about 0.3N, about 0.4N, about0.5N or greater. In some variations where the material exhibits littlehysteresis on it stress/strain curves, the loading force and theunloading force at a particular level of strain may be the same orsimilar.

FIGS. 3A to 4D depict one example of an applicator 100 that may be usedto generate the strain and/or maintain strain in the device forapplication to a treatment site. The applicator may comprise a resilientelastic or spring body comprising an expanded or relaxed configuration(as shown in FIGS. 3A to 3D) and a retracted or constrainedconfiguration (as shown in FIGS. 4A to 4D). The applicator 100 maycomprise an elastic body 102 with first and second device attachmentstructures 104 and 106 that are configured to releasably engage theapplicator attachment structure 40 and 42 of the treatment device 2illustrated in FIGS. 1A to 2B. Here, the attachment structures 104 and106 comprise a plurality of projections 108 and 110 that may be insertedinto the openings 44 and 46 of the devices. The projections may have anyof a variety of shapes, orientations, sizes or thicknesses. In thisparticular variation, the projections 108 and 110 are angled upwardsfrom the base structures 112 and 114 of the applicator 100 (e.g. awayfrom an attached device). The angle may be anywhere in the range ofabout 0 degrees to about 90 degrees or more, in some variations about 15degrees to about 75 degrees, and in other variations about 25 degrees toabout 45 degrees. The angles of the projections 108 and 110 may beuniform or non-uniform between the two sets or between individualprojections. The shape of the projections may be square, rectangular,triangular, bulbous, mushroom-like, or the like. In some variations, thetransverse dimension of the projections may be greater than thecorresponding transverse dimension of the openings 44 and 46 of thetreatment device 2, which may result in stretching or deformation of theopenings 44 and 46 when attached to the applicator 100. The resistancefrom the deformation of the openings 44 and 46 may reduce the rate ofinadvertent detachment of the treatment device 2 from the applicator100. In variations comprising a mushroom or bulbous configuration, therounded distal end of the projection may reduce the risk of damaging thedevice during loading, while the increased transverse dimension of theprojection distally and the reduced transverse dimension of theprojection proximally may provide tactile feedback to the user duringloading that may indicate proper loading, and may also reduce the riskof device damage by reducing stretching of the openings once loaded. Theprojections may have a length of about 500 microns to about 5 mm ormore, in some variations about 1 mm to about 4 mm, and in othervariations about 2 mm to about 3 mm. The thickness of the projectionsmay be the same, lower or greater than the elastic body 102 of theapplicator 100. The elastic body 102 may comprise any of a variety ofelastic materials, including but not limited to polymeric and metallicmaterials. In other variations, generally malleable polymeric ormetallic materials may be used.

To facilitate the application of pressure against the device 2 and ontothe skin, the base structures 112 and 114 may further comprise pressurepads 116 and 118 or other padded/deformable structures that may conformto the contours of the skin surface, which may redistribute forcesexerted onto the treatment device 2 through the applicator 100 acrossthe surfaces of the pads 116 and 118. The pressure pads 116 and 118 maycomprise any of a variety of deformable materials, including foams (openand closed cells), gels, and the like.

In some variations, the device may comprise further indicia that may beused to indicate proper loading and/or straining of the device. In FIGS.1A and 2A, for example, the geometry of lines 74 and 76 may be remaingenerally linear when all of the openings 40 and 42 of the treatmentdevice 2 are engaged by the projections 108 and 110, but may be deformedor become non-linear if one or more of the openings 40 and 42 aremissed, due to variations in the degree of stretching across thetreatment device 2. The lines 74 and 76 may also align withcorresponding indicia on the applicator 100 (e.g. the base structures112 and 114 and/or the pressure pads 116 and 118) to indicate properloading and/or stretching of the treatment device 2.

In some variations, the applicators may be manually maintained in aretracted state by the user during loading by squeezing or otherwiseexerting compressive forces onto the applicator. In other variations, asshown in FIGS. 3A to 4D, the applicator 100 may comprise a lockingmechanism 120 that may be used to maintain the applicator 100 in one ormore configurations. In this particular variation, the locking mechanism120 comprises a latch 122 that releasably engages a tab 124 located inan opening 126 or recess of the elastic body 102. The latch 122 may bebiased against the tab 124 such that as the tab 124 slides along thelength of the latch 122 as the elastic body 102 is compressed, until thetab 124 engages a tab opening 134 (depicted in FIGS. 4A, 4C and 4D) onthe latch 122 and locks in the compressed configuration of the elasticbody 102. To resist complete disengagement between the latch 122 and theopening 126 in the elastic body 102, the opening 126 may comprise aretention bar 128 that the distal section 130 of the latch 122 may bewrapped around. The latch 122 may be attached to the elastic body 102 bya rivet 132, or by welding or gluing, for example. In other examples,the latch may be integrally formed by laser cutting or punching out thelatch structure from the elastic body. In some variations, theapplicator may be configured with two or more latches.

In other variations, the latch may not be biased against the tab and maybe manually engaged the user at the desired locking position. In othervariations, the latch may have a plurality of tab openings to permitlocking into a variety of configurations. In still other variations, thelatch may comprise a projection or tab that engages an opening or recessof the elastic body. In alternate variations, the locking mechanism maycomprise a ratchet mechanism, locking pin mechanism, or resistancescrew, for example.

FIGS. 3A to 3D depict the applicator 100 in its base configuration withreduced strain, if any. To facilitate loading of the treatment device 2,the applicator 100 may be compressed, until the applicator 100 is lockedinto a compressed configuration, as illustrated in FIGS. 4A to 4D, whichmay reduce the degree of stretching, if any, needed to load the deviceonto the applicator 100, as depicted in FIGS. 5A and 5B. Once the deviceis loaded, the locking mechanism 120 may be disengaged by pressing thelatch 122 away from the locking tab 124. The potential energy in theelastic body 102 from its compression is then released to permitstretching of the attached treatment device 2 and is ready for adhesionto the skin. As shown, the elastic body 102 comprises a sheet ofsemi-rigid material, but in other variations, may have a frame-likeconfiguration. In some variations, the elastic body may comprisestainless steel with a thickness in the range of about 500 microns toabout 3 mm or more, in some variations about 1 mm to about 2 mm, and inother variations about 1 mm to about 1.5 mm. The elastic body 102 may beconfigured with as a number of angled panel regions, as depicted inFIGS. 3A to 4D, with generally horizontal base structures 112 and 114that may be generally orthogonal to side panels 140 and 142, which inturn form an angle of about 135 degrees each (as measured from theinferior surface of the elastic body 102) with the central panels 144and 146 which in turn may be generally oriented at about a 90 degreeangle with each other. The angles between the panels may be sharp anglesor rounded angles, and may be configured differently depending upon theparticular skin site (e.g. limb vs. torso), or degree of desired strain(e.g. a more obtuse angle between the central panels 144 and 146). Inother variations, the angle between any two panels or base structure maybe in the range of about 0 to about 360 degrees, in some variationsabout 45 to about 135 degrees, and in other variations about 75 to about90 degrees (as measured from the underside or topside of the elasticbody 102). The latch mechanism 120 may be attached or involve thecentral panels as shown in FIGS. 3A to 4D, but in other variations maybe attached or involve the side panels or base structures. In othervariations, the elastic body may comprise a curved structure, includingbut not limited to an omega-shaped structure. As illustrated in FIGS. 3Ato 5B, the non-planar configuration of the applicator 100 provides anopen region 150 between the pressure pads 116 and 118 and side panels140 and 142, which permits access to the superior surface of an attacheddevice to facilitate positioning of the device to a treatment siteand/or to permit direct access or the application of pressure to thecentral portion of a device by the user (e.g. using fingers or otherinstrument). As shown in FIGS. 5A and 5B, the treatment device 2 and theapplicator 100 may be configured so that the inner adhesive regions 20and 22 are generally located underneath the pressure pads 20 and 22 whenthe treatment device 2 is loaded onto the applicator 100.

In other variations, the applicators usable with the wound treatmentdevice may not be configured to actively exert force onto the device,and/or need not have a generally angled or curved design. In FIG. 6, forexample, the applicator 200 has a generally planar configuration andcomprises two device attachment structures 202 and 204 that areconnected by strut or frame members 206 and 208 that are configured toslide or move with respect to at least one of the device attachmentstructures 204, if not both. In FIG. 6, for example, the strut or framemembers 206 and 208 may be fixedly mounted to one of the attachmentstructure 202, but are slidably mounted to the other attachmentstructure 206 by clamps 210 and 212. The clamps 210 and 212 depicted inFIG. 6 are friction clamps that may be pinched or compressed to at leastpartially release or relieve the frictional resistance between the framemembers 206 and 208 and the clamps 210 and 212, which permits separationor contraction of the applicator 200. The attachment structures 206 and208 may further comprise tabs 214 and 216 or handles to facilitatemanipulation and/or positioning of the applicator 200. In use, the userwill attach a device 2 to the applicator 200, and then manually stretchthe device 2 by pulling apart the clamps 210 and 212. To use thisapplicator 200, the attachment structure 204 is slid toward the otherattachment structure 202 along frame members 206 and 208 until thespacing between the attachments structures 202 and 204 is sufficientlyreduced to facilitate attachment of a complementary treatment device(not shown) without requiring significant stretching, if at all. Onceattached, the attachment structure 204 is pushed or pulled away from theother attachment structure 202 until the desired degree of stress orstrain in the treatment device is achieved. The treatment device is thenapplied to the treatment site, and then the attachment structure 204 isslid along the frame members 206 and 208 again to relieve the stress andstrain in the treatment device and to permit separation of theapplicator 200 from the treatment device.

In the particular variation depicted in FIG. 6, the applicator 200comprises two frame members 206 and 208 located on the periphery of theapplicator 200 to provide a central access region 218 that mayfacilitate positioning of the attached device or to direct access to thedevice. In other variations, the applicator may comprise a single framemember or three or more frame members, and the applicator may compriseone or more frame members that are centrally located or otherwise spacedaway from the periphery of the applicator. In other variations, othertypes of movable or lockable mechanical interfaces may be providedbetween the frame members and the attachment structures, including butnot limited to locking pins, thumbscrews, and the like. In anothervariation, helical springs may be provided along the frame members to206 and 208 to bias or exert a separation force between the attachmentmembers 202 and 204. In still other variations, such as the applicator220 depicted in FIG. 12A, force members 222 and 224, which may be coilor pneumatic struts, for example, may also be used.

FIGS. 11A and 11B depict another variation of an applicator 320comprising bendable or deformable frame members 322 that may or may notbe biased to a configuration that exerts a stretching force on anattached device. In this particular variation, the bendable framemembers 322 comprise a frame member 322 with a hinge 324, but in othervariations, other mechanical joints, or a malleable or other deformableframe member may be used. The applicator 320 may be bent or angled tofacilitate loading of a device onto its attachment structure 326. Onceattached, the device may be strained by straightening the configurationof the frame member 322, as shown in FIG. 11B. The frame member 322 maybe maintained in the straight configuration using a locking sleeve 328that is positioned over the hinge joint to restrict motion. The sleeve328 may be configured to slide and/or rotate in and out of lockingposition, and may or may not reduce the risk of inadvertent unlocking.

The length of the attachment structures of the applicator may vary, andas depicted in FIG. 7, the applicator 240 may comprise two or moreelastic bodies 242 and 244, each of which may have a locking mechanism246 and 248, and a central access region 250 between the elastic bodies242 and 244, which may facilitate device placement by permittingvisualization of the treatment site. In other variations, such as theapplicator 220 in FIGS. 12A and 12B, the force members 222 and 224 maybe separately coupled to the attachment members 226 and 228 from thelocking mechanism 230, e.g. the locking mechanism may be attached to theattachment members 226 and 228 rather than the force members 222 and224. In FIG. 12A, the locking mechanism 230 comprises complementaryratchet/toothed members 232 and 234 that engage once the applicator 220is sufficiently squeezed or retracted. In contrast to the lockingmechanism 120 described in FIGS. 3A to 5B, the locking mechanism 230 inFIG. 12A is able to lock the applicator configuration across a rangeaccording to the degree of overlap or engagement between theratchet/toothed members 232 and 234. To release or separate the lockingmechanism 230, a tab, handle, or ring 236 may be provided on one or bothratchet members 232 and 234 to facilitate disengagement.

As illustrated in FIGS. 8 and 9, to facilitate conforming a woundtreatment device to a treatment site, the applicators 260 and 280 may beconfigured with attachment structures 262 and 282, respectively, thatare able to bend or deform along their longitudinal lengths. In FIG. 8,for example, the attachment structures 262 comprise hinge mechanisms 264that permit bending at one or more locations. The hinges 264 may or maynot be configured to limit the degree or range of bending. In FIG. 9,the applicator 280 comprises attachment structures 282 with segments284, 286 and 288 that are attached by bendable or deformable wires 290or struts. In this particular variation, each wire 290 spans all threesegments 284, 286 and 288, but in other variations, one or more wiresmay be configured to span two or less than all of the segments.

In some variations, the attachment structures of the applicator may ormay not comprise discrete segments but may comprise a material orconfiguration that permits flexion along their longitudinal length. Instill other variations, the attachment structures may have non-linear ornon-planar configurations. In FIG. 10, for example, the applicator 300comprises an attachment structure 302 with a fixed curvature orcurvilinear configuration. In still other examples, the applicator mayhave a curved or curvilinear base configuration, but may elasticallydeform in one or more directions. The degree of curvature may vary andmay or may not comprise an arc of a circle or oval structure. The curvedattachment structures may be used with applicators 300 comprising framemembers 304, for example, or with applicators with comprising sheet orleaf spring members, for example.

In one variation, to use the wound treatment system, the patient may bepositioned so that the incision site is in a non-stressed, tension freeposition. For an abdominoplasty incision site, for example, the patientmay be standing up or lying in supine position, and for a breastincision site, the patient may be lying in the supine position. Theincision site may then be cleaned with an agent alcohol or othercleaning agent. In some further variations, a separate skin adhesive oradjunctive agent (e.g. tincture of benzoin) may be applied adjacent tothe incision site prior to the application of a bandage.

An applicator may be manipulated into a retracted position and thenlocked to that position. In some variations, the locking occursautomatically, while in other variations, the locking is manuallyactuated. Referring to FIGS. 13A to 13D, and using the treatment device2 in FIG. 1A and the applicator (not shown), for example, the applicatormay be squeezed or compressed until the latch automatically snaps intoposition. A treatment device 2 is oriented with the adhesive surface (orrelease liner 56) facing away from the applicator and then attached tothe device attachment structures of the applicator, e.g. by insertingthe attachment projections and through the retention openings 44 and 46of the treatment device 2. In some variations, some stretching of thedevice may occur as the device is attached to the applicator, and insome instances, the release liner of at least the inner adhesive regions20 and 22 may be removed to facilitate the stretching. This may beperformed between the engagement of the two sets of openings 44 and 46of the treatment device 2, for example, or after the attachment of thetreatment device 2 to the applicator is completed. Once the attachmentof the treatment device 2 has been confirmed, the applicator may bereleased from the locked position, e.g. by actuating the latch to strainthe device, as depicted in FIG. 13B. In some variations, markings orindicia on the treatment device 2 (e.g. lines 74 and 76 of the treatmentdevice 2 in FIG. 2A) may be used to assess proper attachment of thedevice to the applicator. In some examples, the applicator may besqueezed to facilitate unlatching. Once unlocked, the applicator exertsa separation force that pushes apart the attachment sites of the deviceto a pre-determined strained configuration.

To apply the device 2, the device 2 may be oriented by identifying thecentral non-adhesive region 18 of the treatment device 2 and aligningthis region with a wound or incision site 90. Pressure is applied to theapplicator to secure the treatment device 2 to the site 90. In somevariations, the foam structures (or other pad structures) of theapplicator are compressed or otherwise deformed as the applicator ispushed against the skin. In some examples, the user may also applymanual pressure directly to the device and against the skin by insertinghis or her fingers between the device attachment sites of theapplicator. The site 90 may or may not already be closed using sutures92 or other wound closure devices, e.g. staples, glues, and the like. Invariations, the site 90 may be closed with subcutaneous sutures but notcutaneous sutures.

Once the treatment device 2 is secured to the site 90, the applicatormay be disengaged from the device by squeezing the applicator. In somevariations, one device attachment site of the applicator may be held inplace (e.g. the “thumb” side of the applicator as it is held by theuser) while the other device attachment site is released from theretention apertures of the device (e.g. displacing the “finger” side ofthe applicator toward the “thumb” side of the applicator). Once one sideof the device is released, the applicator may be detached from the otherside of the device, e.g. by withdrawing the attachment projections ofthe applicator from the remaining retention apertures. In examples wheremultiple devices are placed, the above steps may be repeated until theentire incision site is covered. In some variations, the multipledevices are placed edge-to-edge with adjacent devices while reducing anyoverlap or gaps between the devices. The release liner of the end flapsmay be removed and the end flaps 48 and 50 may be secured to the skinusing finger pressure. The end flaps may or may not be stretched ortensioned by the user before being pressed against the skin.

FIGS. 50A to 50F illustrate one variation of a tensioning device,straining device or applicator 900. The applicator 900 comprises anactuator or handle 901 having a first handle member 902 with pivot arm904 and a second handle member 903 with second pivot arm 905. Attachmentstructures 906, 907 are respectively coupled to distal portions of pivotarms 904, 905. Attachment structures 906, 907 each comprise an elongateportion 908 having one or more tabs or extensions 909 extending from theelongate portion 908. The extensions 909 may be used to attach to a skintreatment device such as, for example, as described with respect to theskin treatment device 2010 and attachment device 2003 illustrated inFIGS. 63A and 63B herein. Alternative attachment structures may be usedas discussed in further detail herein.

The handle members 902, 903 are pivotally coupled by connector 910 atthe pivot arms 904, 905 to provide a pivot point or fulcrum, to transferforce from the handle 901 of applicator 900 to a skin treatment devicewhen coupled to the attachment structures 906, 907, to thereby strainthe skin treatment device prior to placement on skin.

FIG. 50A illustrates an actuator or handle configuration prior tostraining a skin treatment device for application to the skin of asubject. A skin treatment device may be attached to the attachmentstructures 906, 907. When an external force is applied to the actuator,e.g., the handle members 902, 903 of the handle 901 are squeezedtogether, the force is transferred to provide a separation force betweenthe attachment structures 906, 907 coupled respectively to pivot arms904, 905. Optionally, the handle may be provided with a distance d2 fromthe top 911 to the fulcrum or pivot point 912 that is greater than thedistance d1 from the pivot point 912 to an attachment structure 906 or907. Thus, the actuator or handle may provide a mechanical advantagegreater than 1 when actuated. In some variations, d2 may be greater thand1 by at least about 10%, about 20% about 30%, about 40%, about 50%about 76% or about 100% or more. In other examples, d2 may be measuredfrom the midpoint of the handle, rather than the top of the handle.

FIG. 50B illustrates the applicator 900 in a strained configuration. Forpurposes of clarity, an attached skin treatment device is not shown, butthe pocketed skin treatment devices illustrated in FIGS. 43A to 43C, forexample, may be adapted for use with applicator 900. The handle members902, 903 have been squeezed together and a separation force has beenexerted between the attachment structures 906, 907 to strain an attachedskin treatment device 930 (shown in FIG. 50F). The applicator 900 may ormay not have a mechanism to lock to maintain the skin treatment devicein a strained configuration. In the variation depicted in FIGS. 50A to50F, the handle members 902, 903 are lockable together by a lockingmechanism 915 that may be locked to prevent or resist separation of thehandle members 902, 903 and unlocked to release the strain exerted onthe skin treatment device. FIG. 50C depicts the locking mechanism 915 isprior to closure of the handle members 902, 903, and FIG. 50D depicts itafter closure of the handle members 902, 903.

Referring to FIGS. 50C and 50D, the locking mechanism 915 comprises aspring loaded catch 916 in handle member 902 that is depressed by cammedsurface 920 of cavity in handle member 903, as the handle members 902,903 close. The catch 916 may be biased upward into notch 917 afterhandle members 902, 903 close. The catch 916 may be released fromengagement in notch 917 by depressing release member 918 to compressspring 919 and separating handle members 902, 903. Thus the attachmentstructures 906, 907 may be released from an attached skin treatmentdevice after application to the skin. By locking the applicator in astrained position a predetermined strain of a given skin treatmentdevice may be achieved. Other locking mechanisms, including but notlimited to other locking mechanisms described herein may be used. Avariable locking mechanism may be used to vary the amount of strain fora given skin treatment device.

The attachment structure profile may be straight, curved or otherwisevaried. For example, the shape of the attachment structures may beconfigured to follow the shape of the area of the subject's body towhich the skin treatment device is to be attached. In accordance withanother variation the applicator 900 is illustrated with curved orcurvable attachment structures 906, 907. As shown in FIG. 50E torsionsprings 922, 923 are respectively coupled to pivot arms 904, 905.Torsion spring arms 924, 925 (with spring tips 924 a, 925 a to apply adownward force) extend along elongated portions 908 of attachmentstructures 906, 907 respectively. The biases of the spring arms 924, 925and tips 924 a, 925 a, apply a downward force to cause the attachmentstructures 906, 907 to bend to form a curved skin treatment device 930.As shown in FIG. 50F, a curved or shaped skin treatment device 930 maybe applied to a curved or shaped surface 928 of a subject's skin. Theamount of torsion in the springs 922, 923 may be varied to provide avarying degree of curvature. A tensioning device or applicator may beselected or configured to have a profile that has a desirable profilefor a particular body location or profile where the skin treatmentdevice is to be placed on a subject's skin. A tensioning device orapplicator may be selected or configured to closely match a portion of asubject's body profile, as shown in FIG. 50F, where a concavely shapedside of the skin treatment device generally matches the convex shape ofthe subject's body profile where the device is to be attached. Theattachment structures may be curved, curvable, bendable, deformable,shapeable or movable to provide alternative shapes or profiles of anattached skin treatment device.

To remove the handle 901 from the skin treatment device, the releasemember 918 may be actuated so that the handle members 902, 903 may beseparated, thereby separating the attachment structures from theattachment features of the skin treatment device. A variety of methodsand devices may be used to provide for an easy separation of theattachment structures of an applicator from the attachment features ofthe skin treatment device including but not limited to the separationdevices and methods described herein.

FIGS. 51A to 51D illustrate another variation of a tensioning device,straining device, or applicator 1000. Here, the applicator 1000comprises an actuator or handle 1001 having a screw handle 1002 andthreaded post 1003. The screw handle 1002 comprises a complementarilythreaded lumen that may be rotated to advance it up or down the threadedpost 1003. A stop 1005 at the top of threaded post 1003 may be providedto resist or prevent the screw handle 1002 from advancing beyond the topof the threaded post 1003. A sliding collar 1004 is positioned on thepost 1003 below the screw handle 1002. Lever arms 1010, 1011 have firstend portions 1012, 1013 respectively that are pivotally coupled to thesliding collar 1004 at pivot points 1020, 1021. Second or opposite endportions 1014, 1015 are pivotally coupled to attachment structures 1006,1007 by way of attachment bars 1016, 1017 at pivot points 1022, 1023respectively. Attachment bars 1016, 1017 are also pivotally attached tothe bottom of the post 1003 at pivot points 1024, 1025.

Attachment structures 1006, 1007 may be respectively coupled to distalportions 1014, 1015 of pivot arms 1010, 1011. Attachment structures1006, 1007 each comprise an elongate portion 1008 having one or moretabs or extensions 1009 extending from the elongate portion 1008. Theextensions 1009 may be used to attached to a skin treatment device suchas, for example, as described with respect to the skin treatment device2010 and attachment device 2003 illustrated in FIGS. 63A and 63B herein.Alternative attachment structures, and corresponding attachmentconfigurations on the skin treatment devices that may be used arediscussed in further detail herein. The attachment structure profile maybe straight, curved or otherwise varied. For example, the shape of theattachment structures may be configured to follow the shape of the areaof the subject's body to which the skin treatment device is to beattached, may be curved, curvable, bendable, deformable, shapeable ormovable to permit various skin treatment device shapes to be formedincluding but not limited to, as shown in FIG. 50F herein.

FIGS. 51A and 51C depicts the applicator 1000 in an unstrained position,with the screw handle 1002 is in a relative position advanced downwardfrom the stop 1005 of the post 1003. The attachment structures 1006,1007 are pivoted or angled in with respect to each other and are in aclosed position where the distance between them is smaller than whenstrained. This position facilitates loading or release of a skintreatment device from the applicator.

As shown in FIGS. 51B and 51D, when the screw handle 1002 is rotated toadvance the post 1003 inferiorly, the post 1003 pushes relativelydownward on attachment bars 1016, 1017 at pivot points 1024, 1025 whilelever arms 1010, 1011 move relatively upward with collar 1004, therebypulling up on attachment bars 1016, 1017 at pivot points 1022, 1023 andapplying forces that separate and outwardly rotate the attachmentstructures 1006, 1007 into a flatter more planar configuration withrespect to each other. As the screw handle 1002 is rotated moving thedevice from an unstrained towards a more strained configuration, thestructures of the handle 1001 hold the attachment structures 1006, 1007in position. Thus the handle 1001 holds or locks the applicator 1000 inits relative strained position. Various positions of the screw handle1002 on the post 1003 may correspond to various degrees of strain of aparticular skin treatment device. Markings may also be made on the postto identify a relative strain of a skin treatment device with respect toscrew handle 1002 positions.

To remove the handle 1002 from the skin treatment device, the screwhandle 1002 may be rotated in an opposite direction so that theattachment structures move inward and rotate to separate them from theattachment features of the skin treatment device. The number of handleturns to move applicator 1000 from an unstrained to strain position, andvice versa, may vary from about a half-turn to about 1, 2, 3, 4, 5, 6,7, 8, 9, 10 or more turns, depending upon the pitch of the threading.The pitch of the helical threading (i.e. the width of one complete turn)may be selected depending upon the desired mechanical advantage and/orself-locking effect, e.g. resisting rotation that may occur from anattached skin treatment device squeezing attachment bars 1016, 1017.Typically, smaller pitches may be used to increase the mechanicaladvantage or self-locking feature, but may be more tedious tomanipulate.

FIGS. 52A to 52H, illustrate another variation of a tensioning device,straining device, or applicator 1030, comprising an actuator or handle1031 having a body 1033 with a cam handle 1032 and locking tabs 1050.The cam handle 1032 may be rotatably positioned on top of the body 1033and attached to a cam 1055 which is positioned under the body 1033. Atleast one of parallel u-bars 1040, 1041 is slidably mounted on at leastone of posts 1034, 1035, which are attached to the handle body 1033 withmounts 1045. As shown, in FIGS. 52A and 52C, post 1034 extends throughand can slide through opening 1048 in u-bar 1040. Post 1035 extendsthrough and can slide through opening 1049 in the u-bar 1041. U-bars1040, 1041 further comprise inner surfaces 1042, 1043 that interact withcam surfaces 1052, 1053 or cam 1055.

The bars 1040, 1041 couple skin treatment device attachment structures1036, 1037 to body 1033 of the applicator 1030. Attachment structures1036, 1037 are coupled to struts or legs 1058, 1059 of u-bars 1040,1041. In other variations, rather than a u-shaped bar, a single strut ora group of three or more joined struts may be provided, and the strutsmay or may not be parallel relative to one another, or perpendicular tothe body of the applicator 1030, e.g. the struts may be acutely orobtusely angled. As illustrated in FIG. 52A, attachment structures 1036,1037 each comprise an elongate portion 1038 having one or more tabs orextensions 1039 extending from the elongate portion 1038. The extensions1039 may be used to attach to a skin treatment device such as, forexample, as described with respect to the skin treatment device 2010 andattachment device 2003 illustrated in FIGS. 63A and 63B herein.Alternative attachment structures may be used as discussed in furtherdetail herein. The attachment structure profile may be straight, curvedor otherwise varied. For example, the shape of the attachment structuresmay be configured to follow the shape of the area of the subject's bodyto which the skin treatment device is to be attached, may be curved,curvable, bendable, deformable, shapeable or movable to permit variousskin treatment device shapes to be formed including but not limited to,as shown in FIG. 50F herein.

FIGS. 52A, 52C, 52E and 52G show the applicator 1030 in an unstrainedposition. The u-bars 1040, 1041 are in relatively close parallelposition with respect to each other. Thus the attachment structures1036, 1037, coupled to the bars are relatively close with respect toeach other to facilitate the loading of an unstrained skin treatmentdevice on to the attachment structures 1036, 1037.

As shown in FIGS. 52B and 52D, the cam handle 1032 is rotated, the camsurfaces 1052, 1053 interact with the inner surfaces 1042, 1043 of thebars 1040, 1041 to apply a separating force between the u-bars 1040,1041 and thus to attachment structures 1036, 1037 to thereby strain anattached skin treatment device (not shown). The skin treatment devicesillustrated in FIGS. 43A to 43C may be adapted for use with applicator1030. As the cam handle 1032 is rotated about point 1051 using anexternal force, the cam 1055 moves the device from an unstrained towardsa more strained configuration where bars 1040, 1041 are in a moreseparated, generally parallel position with respect to each other. Thelocking tabs 1050 may be depressed to lock the applicator 1030 in itsrelative strained position, i.e. to maintain the strain of the skintreatment device. The locking tabs 1050 when moved to the lockingposition as shown in FIG. 52H interfere with movement u-bars 1040, 1041by engaging inner walls 1042, 1043. When the applicator 1030 is in anunstrained position, the locking tabs extend above housing 1033 (asdepicted in FIG. 52G).

To remove the handle 1031 from the skin treatment device, the lockingtab 1050 is released to the position illustrated in FIG. 52G so that thecam handle 1032 may be rotated in an opposite direction. This moves theattachment structures 1036, 1037 closer together and permits theattachment structure 1036, 1037 to separate from the attachmentfeatures, e.g., pockets or hook or loop structures, of the skintreatment device.

FIGS. 53A to 53E depicts another variation of a tensioning device,straining device, or applicator 1100, comprising a handle 1101 oractuator configured to be actuated to strain a skin treatment deviceand/or to apply the device to the skin of a subject. The applicator 1100includes attachment structures 1106, 1107. In the variation illustratedin FIGS. 53A to 53E, the attachment structures comprise spring loadedbinder type clips that grasp or pinch ends of a skin treatment device oran attachment structure on ends of the skin treatment device, but theapplicator or skin treatment device attachment structures may compriseother types of attachment structures or features, including but notlimited to other attachment structures and features set forth herein.

The applicator 1100 may further comprise a moveable, slidable or acollapsing or expanding top frame structure 1102, opposing stationarywalls 1108, 1109 and opposing movable, pivotable or hinged walls 1110,1111. Frame structure 1102 comprises a pair of slidable elements 1120,1121 and pair of slidable elements 1122, 1123. Each of the pair ofslidable elements 1120, 1121 and 1122, 1123 can slide together into aclosed position (FIGS. 53A and 53C) where there is a first distance d1(depicted in FIG. 53C) between walls 1108 and 1109. The pairs ofslidable element 1120, 1121 and 1122, 1123 can slide apart into a secondopen position where there is a second distance d2 (depicted best in FIG.53D) between the walls 1108, 1109 and where the distance d2 is greaterthan the distance d1.

Hinged wall 1110 comprises a first and second wall portions or segments1112 a, 1113 a that are movably, pivotally or hingedly connected to eachother by connector 1114 a, at a pivot point. Hinged wall 1111 comprisesa first and second wall segments 1112 b, 1113 b that are movably,pivotally or hingedly connected to each other by connector 1114 b at apivot point. Wall segments 1112 a and 1113 b are movably, pivotally orhingedly coupled respectively to opposite end sides 1108 a, 1108 b ofwall 1108. Wall segments 1112 b and 1113 a are movably, pivotally orhingedly coupled respectively to opposite end sides 1109 b, 1109 a ofwall 1109. The walls 1108, 1109, 1110, 1111 are coupled to the framestructure 1102 to form a box-like structure with an opening (when in thestrained configuration) to provide access to a skin treatment deviceattached across the bottom of the applicator to attachment structures1106, 1107. The access allows a user to apply pressure to a skintreatment device as or after it is applied to a skin surface beforeremoving the applicator 1100. Alternatively, a pressure applicationdevice may be coupled to the applicator and actuable to provide pressurethrough the opening to a skin treatment device as or after it is beingapplied.

FIGS. 53A and 53C illustrate the applicator 1100 in a first, unstrainedposition. The frame structure 1102 is in a collapsed position whereslidable supports or elements 1120, 1121 and slidable elements 1122,1123 are in a folded closed position. In this position, subsupports orwall segments 1112 a and 1113 a are pivoted to form a v-shape extendingoutward of the applicator, and wall segments 1112 b and 1113 b arepivoted to form a v-shape extending outward of the applicator 1100 sothat the distance between end walls is a distance d1. This configurationmay facilitate loading of an unstrained skin treatment device. After anunstrained device is loaded, the skin treatment device is strained byapplying pressure to the v-shaped walls 1110, 1111 (for example bymanually squeezing the v-shaped or collapsed walls shown in FIGS. 53Aand 53C). This action forces the pairs of sliding elements 1120, 1121and 1122, 1123 into a spread, elongated or open position, as shown inFIGS. 53B, 53D and 53E. In the spread or open position, the framestructure 1102 transferring a separation force from the wall segments1112 a and 1113 a to the skin treatment device to strain the skintreatment device along a strain axis. When the applicator 1100 is in thestrained position, as shown in FIG. 53E, the wall segments 1112 a, 1113a and 1112 b, 1113 b of walls 1110 and 1111 may be configured to pivotslightly inward and/or off-center to lock the applicator 1100 into placeor to resist collapse of the walls back into the v-shaped configuration.Thus, the applicator 1100 and an attached strained skin treatment devicemay be configured to maintain or lock in a strained configurationwithout continuous user applied force.

Grasping members 1105 may be provide to facilitate grasping of thedevice when applying a skin treatment device to the skin of a subject.Although each of the grasping member 1105 are depicted to opposite sidesof their respective pivot connectors 1114 b, in other example, thegrasping members may be located on the same sides of their respectivepivot connectors, or lie across or on both sides of the pivotconnectors.

In some variations, the use of two opposing and collapsible walls toseparate to slidable walls of a fixed configuration, as illustrated inthe applicator 1100 depicted in FIGS. 53A to 53E, as wells similarapplicators such as those illustrated in FIGS. 54A to 54I, FIGS. 56A to57I, for example, may provide a mechanical advantage when applying astrain to a skin treatment device. A mechanical advantage may becharacterized by an output force that is greater than the input force,and may be described as a ratio of the output force divided by the inputforce that is greater than 1. In some variations, the mechanicaladvantage may be at least about 1.1, about 1.2, about 1.3, about 1.4,about 1.5 about 1.7, or about 2 or more. The mechanical advantage may ormay not be provided throughout the entire movement range of theapplicator.

Referring to FIG. 54J, the mechanical advantage of the collapsing box,with two opposing slidable walls having a fixed configuration separatedby initial distance d2 and two collapsible opposing walls, eachcomprising two wall segments of length d1 and forming an angle α betweena wall segment and an intersecting midline may be calculated as:F _(x) =F _(y)/Tan α

The width of the slidable walls d3 permits skin treatment devices of upto a comparable width d3, which may affect the absolute level of forcenecessary to strain the attached skin treatment device, but may notdirect impact the mechanical advantage provided by the collapsing boxdesign. It is noted from the above equation that where angle α isinitially 45 degrees at a 0% strain, a mechanical advantage is providedalong the entire strain process. Thus, in some variations, theapplicator may be configured to have an initial angle α of about 45degrees, but in other examples, the initial angle α may be in the rangefrom about 1 degree to about 90 degrees, sometimes about 15 degrees toabout 75 degrees, and other times about 30 degrees to about 60 degrees,and still other times about 30 degrees to about 45 degrees. However, useof an initial angle α that is less than about 45 degrees at 0% strainmay permit a greater degree of straining, compared to designs with aninitial angle α of about 45 degrees or more. In some designs where aninitial angle α of less than about 45 degrees is used, although noinitial mechanical advantage, the absolute level of force to be exertedby the user to generate the initial, smaller strains (e.g. up to about10% or about 20% strain) in the skin treatment device may not besignificant compared to the absolute greater strains needed for higherlevels of strain (e.g. about 40% or about 60% strain).

FIG. 54K is a table that lists the resulting load based upon acollapsing box applicator design attached to a 6 cm dressing, where thecollapsible walls are configured with an angle α of about 45 degrees ata strain of o %. As depicted in the graph of FIG. 54L, the plot of theforce exerted by the user at each level of strain (10%, 20%, 30% and40%) is generally at or below the level of force generated by theapplicator. In this particular configuration, the user input forcegradually increases from about 0% to about 20%, then plateau to about30%, and then decreases toward zero at a strain of about 40%.

FIG. 54M is a table that lists the resulting load for a collapsing boxapplicator design attached to a 6 cm dressing, where the collapsiblewalls are configured with an angle α of about 40 degrees at a strain of0%, and also where strains up to 60% were measured. As shown in thegraph of FIG. 54N, the plot of the force exerted by the user at eachlevel of strain (10%, 20%, 30%, 40%, 50% and 60%) at or slightly abovethe output force until angle α is about 45 degrees (approximately 12%strain) but is at or below the level of force generated by theapplicator for greater strains (e.g. about 20% to about 60%).

FIG. 54O is a table that lists the user input force required to maintaina constant output force (here normalized to 1 Lbf) from a strain of 0%to 60%. As shown in the graph of FIG. 54P, to generate a constant forceacross for strain up to 40%, the required user input force is initiallygreater until angle α is about 45 degrees (approximately 12% strain),then gradually decreases (at a generally constant slope) as the level ofstrain increases (up to a strain of 40% is depicted in FIG. 54P).

Other examples of applicator designs that may be configured with amechanical advantage are described elsewhere herein.

FIGS. 54A to 54D illustrate another variation of a tensioning device,straining device or an applicator 1200. The applicator 1200 comprises ahandle 1201 or actuator configured to be actuated to strain a skintreatment device 1240 and/or to apply the device to the skin of asubject. The applicator 1200 includes end attachment structures 1206,1207. In some variations, the applicator may also include sideattachment structures 1203, 1204, 1220, 1222 that may interface withstructures 1203 and 1204 be attached to the sides of a skin treatmentdevice. This interface may provide a second dimension or axis to thetension or strain applied to the skin treatment device. Thus the skintreatment device may be strained in orthogonal directions or at leasttwo directions, i.e., the applicator provides a bi-directionally ormulti-directionally strained skin treatment device. The attachmentstructures may be located on the bottom of bump features 1245 on wallsegments 1220, 1222. The attachment structures 1206, 1207 may compriseengagement flaps having edges that engage attachment features 1246, 1247of a corresponding skin treatment device 1240. Attachment structures1203, 1204 as shown are hook or loop structures that have correspondinghook or loop structure attachment features on the back side of the skintreatment device. The applicator or skin treatment device attachmentstructures may comprise other types of attachment structures, includingbut not limited to other attachment structures described or set forthherein.

The applicator 1200 may further comprise moveable, slidable or acollapsing or expanding bottom frame structure 1202, opposing fixedconfiguration walls 1208, 1209 and opposing movable, pivotable or hingedwalls 1210, 1211. Frame structure comprises a pair of slidable elements1220, 1221 and pair of slidable elements 1222, 1223. Each of the pair ofslidable elements 1220, 1221 and 1222, 1223 can slide together into aclosed position (FIGS. 54A and 54C) where there is a first distance d1between walls 1208 and 1209. The pairs of slidable element 1220, 1221and 1222, 1223 can slide apart into a second open or strained positionwhere there is a second distance d2 between the walls 1208, 1209 andwhere the distance d2 is greater than the distance d1 (as depicted inFIGS. 54B and 54A, respectively).

Hinged wall 1210 comprises first and second wall portions or segments1212 a, 1213 a that are movably, pivotally or hingedly connected to eachother by connector 1214 a, at a pivot point. Hinged wall 1211 comprisesa first and second wall segments 1212 b, 1213 b that are movably,pivotally or hingedly connected to each other by connector 1214 b at apivot point. Wall segments 1212 a and 1213 b are movably, pivotally orhingedly coupled respectively to opposite end sides 1208 a, 1208 b ofwall 11081208. Wall segments 1212 b and 1213 a are movably, pivotally orhingedly coupled respectively to opposite end sides 1209 b, 1209 a ofwall 1209. The walls 1208, 1209, 1210, 1211 are coupled to the framestructure 1202 to form a box-like structure with an opening (when in thestrained configuration) to provide access to a skin treatment device1240 attached across the bottom of the applicator to attachmentstructures 1203, 1204, 1206, 1207, 1246, 1247. This access allows a userto apply pressure to a skin treatment device as or after it is appliedto a skin surface, before removing the applicator 1200 from the skintreatment device. Alternatively, a pressure application device may becoupled to the applicator and actuable to provide pressure through theopening to a skin treatment device as or after it is being applied.

FIGS. 54A and 54C illustrate the applicator 1200 in a first, unstrainedposition. The frame structure 1202 is in an unstrained position whereslidable elements 1220, 1221 and slidable elements 1222, 1223 are in aclosed position. Wall segments 1212 a and 1213 a are pivoted to form av-shape collapsed into the box structure of the applicator 1200, andopposing wall segments 1212 b and 1213 b are pivoted to form a v-shapecollapsed into the box so that the distance between end walls is adistance d1. This position facilitates loading of an unstrained skintreatment device onto the applicator 1200.

After an unstrained device is loaded, the skin treatment device isstrained by applying opposing, outward forces to pulling rings 1218,1219, respectively attached to wall segments 1213 a, 1213 b. This forcestraightens side walls 1210, 1211 and pairs of sliding elements 1220,1221 and 1222, 1223 into an elongated or open position as shown in FIGS.54B and 54D, thus transferring a separation force to the skin treatmentdevice to strain the skin treatment device widthwise (relative to itsorientation and use on along a length of an incision). In othervariations, a single collapsible wall attached generally about themidpoints of the fixed configuration walls so only a single pullingforce is used to separate the fixed configuration walls.

When the device is in the strained position as shown in FIGS. 54B, and54D the wall segments 1212 a, 1213 a and 1212 b, 1213 b of walls 1210and 1211 are pivoted. As shown in FIGS. 54B and 54D, the side walls areover center or slightly hyper-extended or pivoted outward to provide astrain in a width wise direction with the force transferred to the skintreatment device through attachment structures 1203, 1204. Thus the skintreatment device may be strained in orthogonal directions or at leasttwo directions, i.e., the applicator provides a bi-directionally ormulti-directionally strained skin treatment device. The applicator 1100may be locked or maintained in a strained configuration by way of overcenter side walls. A latch or other stop such as a spring loaded pin mayengage one or more of inside surfaces of wall segments 1212 a, 1213 aand 1212 b, 1213 b to maintain the applicator in its over center lockedposition.

FIGS. 54E to 54I illustrate other variations of a tensioning device,straining device or an applicator 1200 as previously described withrespect to FIGS. 54A to 54D, including an integrated stamper 1230. Thestamper 1230 is attached to the top of the handle, actuator ortensioning device 1201 of FIG. 54A with connectors 1235 that attach thedevice 1201 to the inside of the stamper side wall 1234. The stampercomprises a handle 1231 coupled to posts 1232 that extend through thetop wall 1238 of the stamper 1230. Posts 1232 are coupled to pressuremembers 1239 inside the stamper 1230. Prior to actuation, the pressuremembers 1239 are positioned within walls 1234, 1242, 1243, 1244 ofstamper 1230 above and the tensioning device 1201 as shown in FIG. 53G.Springs 1233 around the posts 1232 bias the handle 1231 in an upward(not stamping) configuration. Visibility openings 1248, 1249respectively in the handle 1231 and the top wall 1238 of the stamper1230 provide an opening through which the skin treatment device and/orwound can be seen, for positioning of the applicator 1200 in anappropriate location.

As shown in FIGS. 54E, and 54G, when the tensioning device 1201 is in anunstrained configuration, the length of its side walls 1210, 1211 areless than the length of the side walls 1242, 1244 of the stamper 1230.

In FIGS. 54F and 54H, the tensioning device 1201 is in a strainedconfiguration where the side walls 1242, 1244 of the stamper 1230 areapproximately that of the side walls 1210, 1211 of the tensioning device1201. In a strained configuration, an opening 1229 is provided in thetensioning device 1201 sized to receive the pressure members 1239therethrough. When a force is applied to the handle 1231 and thetensioning device 1201 is in a strained configuration, the pressuremembers 1239 extend down into and through the opening 1229 in theapplicator handle 1201, towards the skin treatment device (not shown),to apply a force to areas of the dressing where an adhesive interfacesthe skin of the subject. (FIG. 54I) Thus, where the adhesive is pressureactivated, the stamper 1230 applies a generally even pressure to theskin treatment device. All stampers described herein may be constructedof a foam or other compressible, conformable material which translatesthe force applied to handle 1231 to the skin treatment device (notshown). These other materials include silicones and styrenic blockcopolymers (e.g. Kraton®), in a solid or porous form.

As an option or alternative, the applicator 1200 may be provided withattachment structures 1236, 1237 that comprise a hook or loop structureof a hook and loop attachment mechanism, or any other attachmentstructure described herein. Likewise, side attachment structures 1203,1204 may also be a hook or loop structure or any other attachmentstructure.

FIGS. 55A to 55E illustrate a variation tensioning device, strainingdevice or applicator 1250 comprising a frame 1251 and a pivoting handle1262 that is used to strain a skin treatment device loaded on to theapplicator 1250. The handle 1262 is pivotally attached at a first end1263 to side walls 1256, 1257 near end wall 1255 of the frame 1251. Anopposite second end 1264 of the handle 1262 extends above the frame 1251when the applicator 1250 is in an unstrained configuration as shown inFIGS. 55A, 55C and 55D. The handle 1262 further comprises tensioningarms 1265 pivotally coupled to sides 1266, 1267 of handle 1262 at firstends 1265 a and pivotally coupled to a sliding tensioning bar 1268 at asecond opposite ends 1265 b. Each end 1269, 1270 of the slidingtensioning bar 1268 is configured to slide in slots 1258 extending alonga portion of the length of side walls 1256, 1257 of frame 1251. When thehandle 1262 is squeezed so that its second end 1264 is moved towards theframe 1251, a forced is transmitted from the handle 1262 through pivotpoint at first end 1265 a to tensioning arms 1265 which translate theforce to the sliding tensioning bar 1268 which slides in the slots 1258from the middle towards the end of the frame 1251.

The sliding bar 1268 may further comprise a first attachment structure1286 to which one end of a skin treatment device may be attached. Asecond attachment structure 1287 is positioned on the bottom of thestationary end wall 1255 of the frame 1251. As shown in FIGS. 55A, 55C,and 55D, when in an unstrained position, the sliding tensioning bar 1268is located at the inner end of the slots 1258 where the attachmentstructure 1286 is a shorter distance from the second attachmentstructure 1287 to facilitate attaching or loading of an unstrained skintreatment device. As shown in FIGS. 55B and 55E, in a strainedconfiguration, the sliding tensioning bar 1268 is located at the outerend of the slots 1258 where the first attachment structure 1286 is agreater distance from the second attachment device 1287. In use, thehandle 1262 is moved from the open unstrained position to a secondstrained position transferring the force to the tensioning arms 1265which slide the sliding tensioning bar 1268 the length of the slots1258. When the handle 1262 is closed, it is latched or locked into astrained position by locking or latching mechanism 1275. As shown inFIG. 55C, the locking mechanism 1275 comprises a latch 1277 on the frame1251 which engages a spring biased catch 1278 on the end 1264 of thehandle 1262. A release button 1279 on the end 1264 of the handle 1262may be used to depress the spring loaded catch 1278 to release it fromthe latch 1277.

After the skin treatment device is strained, the applicator 1250 may beused to press the skin treatment device to the skin. As shown in FIGS.55A to 55E, a stamper 1281 with one or more pressure members 1283 may beused to apply a relatively even pressure to portions of the skintreatment device 1285 where an adhesive interfaces with the skin. Thestamper 1281 includes a spring loaded plunger handle 1282 that may beused to apply pressure to the skin treatment device while or after theskin treatment device has been applied to the skin. In other variations,the frame may provide an opening on the superior surface of theapplicator to provide access to the superior surface of the skintreatment device, which allows a user to apply manual pressure to theskin treatment device as or after it is applied to the skin.

The applicator 1250 may also be configured to provide a mechanicaladvantage by providing a substantially longer pivoting handle relativeto the coupling location of the tensioning arms from the pivot point ofthe pivot handle. In some variations, the coupling location as apercentage of the distance from the pivot point to the distal end of thepivoting handle farthest away from the pivot point may be less thanabout 50%, less than about 40%, less than about 30%, or less than about20%, for example.

FIGS. 56A to 56E illustrate another variation of a tensioning device,straining device or an applicator 1300 with a stamper 1330. Theapplicator 1300 comprises a tensioning device 1305 enclosed by a housing1331, a plunger 1332 on the top of the housing 1331, to actuate thestamper 1330 which includes pressure members 1339 positioned orpositionable within or through the tensioning device 1305. Slideactuators or side buttons 1301, 1302 extend from each side 1333, 1334 ofthe housing. The side buttons 1301, 1302 may be manipulated by squeezingthem together to strain an attached skin treatment device in a mannerotherwise similar to that described with respect to actuator 1100 ofFIG. 53A.

The applicator 1300 includes a tensioning structure 1305 comprising amoveable, slidable or a collapsing or expanding frame structure 1325.Frame structure 1325 comprises a pair of arms elements 1320, 1321 andpair of arms elements 1322, 1323. Arm elements 1320, 1321 and armelements 1322, 1323 respectively are slidably coupled so they can expandor collapse the frame structure 1325 by increasing or decreasing thedistance between sides or side walls 1308, 1309 of the frame structure1325. The walls 1308, 1309 may also slide together into a closed orunstrained position (FIGS. 56A, 56C, 56E) or expand to an open orstrained position (FIGS. 56B and 56D).

Attachment structures 1306, 1307 are coupled to and move with side walls1308, 1309. In an unstrained configuration (FIGS. 56A, 56C, 56E), thewalls 1308, 1309 are a first shorter distance from each other tofacilitate loading of an unstrained skin treatment device. In a strainedconfiguration (FIGS. 56B, 56D,) the opposing walls 1308, 1309 are asecond greater distance from each other.

The tensioning structure 1305 may further comprise opposing movable,pivotable or hinge members 1310, 1311. Hinged member 1310 comprises afirst and second hinge segments 1312 a, 1313 a that are movably,pivotally or hingedly connected to each other by way of side button1301, at pivot points 1314 a and 1314 b, respectively. Hinged member1311 comprises first and second hinge segments 1312 b, 1313 b that aremovably, pivotally or hingedly connected to each other by way of sidebutton 1302 at pivot points 1315 a, 1315 b respectively. Segments 1312 aand 1313 b may be movably, pivotally or hingedly coupled respectively toopposite end sides 1308 a, 1308 b of wall 1308. Segments 1312 b and 1313a may be movably, pivotally or hingedly coupled respectively to oppositeend sides 1309 b, 1309 a of wall 1309.

The tensioning structure 1305 further comprises guide structures 1343,1344 coupled to walls 1308, 1309. (FIG. 56E). Guide rods 1341, 1342 areattached to side buttons 1301, 1302 and extend inwardly through guideslots 1345, 1346 of guide structures 1343, 1344 to align movement of thehinge members 1310, 1311 with respect to the frame structure 1325.

FIGS. 56A, 56C and 56E illustrate the applicator 1300 in a first,unstrained position. The tensioning structure 1305 is in a collapsedposition. Segments 1312 a, 1313 a and side button 1301 are pivoted toform a collapsed, folded or v-shape extending outward of the applicator,and segments 1312 b, 1313 b and side button 1302 are pivoted to form aconvex or v-shape extending outward of the applicator 1300 so that thedistance between walls 1308, 1309 is relatively shorter. Thisfacilitates loading of an unstrained skin treatment device. After anunstrained device is loaded, the skin treatment device is strained byapplying pressure to the side buttons 1301, 1302. This forces segments1312 a, 1313 a and segments 1312 b, 1313 b to pivotally move into astraightened, elongated or open position as shown in FIGS. 56B and 56Dand thus transferring a separation force to the skin treatment device tostrain the skin treatment device.

The walls 1308, 1309, and arms 1320, 1321, 1322, 1323 form a box-likestructure with an opening 1329 (when in the strained configuration) toprovide access to a skin treatment device when attached across thebottom of the applicator 1300 to attachment structures 1306, 1307. Thestamper 1330 may be actuated to apply pressure to the skin treatmentdevice by depressing the plunger 1332 to advance the pressure members1339 through the opening 1329 and against a skin treatment device, asand/or after it is being applied. The tensioning device 1305 stays fixedwhen the plunger 1332 is pressed. The pressure members are configured tocompress over the skin treatment device to distribute even forceincluding over non-planer surfaces or body areas. A mechanical, visual,electrical, audible or other indicator may be included in the stamper tosignal when the correct amount of pressure has been applied to theplunger, e.g. a MEMS pressure sensor or a mechanical strain gaugecoupled to the stamper mechanism. As shown, the stamper 1330 may beguided with guide posts 1347, 1348 of guide structures 1343, 1344 thatare received by slots 1351, 1352 in plunger 1332. Guide posts 1347, 1348may include spring members 1349, 1350 that interact with lip 1353 inslots 1351, 1352 to bias the stamper 1330 upward. This resists orprevents the pressure members 1339 from deploying without applying aforce and facilitates reloading by springing stamper 1330 back in to aloading position.

The applicator 1300 is shown in an open or unlocked position in FIGS.56A, 56C and 56E. When the device is in the strained position as shownin FIGS. 56B and 56D, the hinge segments 1312 a, 1313 a and 1312 b, 1313b of side structures 1310 and 1311 may be configured to pivoted slightlyinward and off-center to lock the device into place or to resist orprevent collapse of the walls back into the v-shaped or foldedconfiguration. Springs 1361, 1362 attached to posts 1363, 1364 on armmembers 1320, 1321, and 1322, 1323 respectively bias the arm member1320, 1321, and 1322, 1323 together. Thus, where the tensioning member1305 is in the locked position, the springs 1361, 1362 prevent thesliding members from opening or unlocking. Thus the applicator 1300 maybe maintained or locked in a strained configuration. The springs 1361,1362 also spring the tensioning device back to a loading or unstrainedposition when the device is unlocked for reloading. The springs 1361,1362 help maintain the device in the unstrained configuration tofacilitate loading.

Alternatively, without the stamper 1330, the opening 1329 may provideaccess to a user to apply pressure to a skin treatment device as orafter it is applied to a skin surface. In variations without a stamper,the opening may be enlarged to facilitate manipulation of the skintreatment device manually.

In a variation illustrated in FIGS. 56A to 56E the attachment structures1306, 1307 comprise hook or loop mechanisms. The applicator or skintreatment device attachment structures may comprise other types ofattachment structures, including but not limited to other attachmentstructures described or set forth herein.

FIGS. 57A to 57I illustrate another variation of a tensioning device,straining device, or applicator with a stamper. The applicator 1400comprises a tensioning device 1405 enclosed by a housing 1431; a plunger1432 on the top of the housing 1431 to actuate the stamper 1430. Thestamper 1430 includes pressure members 1439 positioned or positionablewithin or through the tensioning device 1405. Side buttons 1401, 1402extend from each side 1433, 1434 of the housing. The side buttons 1401,1402 are actuable by squeezing them together to strain a skin treatmentdevice attached to the applicator in a manner similar to that describedwith respect to actuator 1100 of FIG. 53A and actuator 1300 of FIG. 56A.

The applicator 1400 includes a tensioning structure 1405 comprising afixed frame structure 1424 and moveable, slidable or a collapsing orexpanding frame structure 1425. Frame structure 1424 comprises opposingside walls 1413, 1414 and end walls 1415, 1416, and middle supportstructure 1417 extending from end wall 1415 to end wall 1416, which incombination form openings 1427, 1428 in frame structure 1424. Openings1427, 1428 may receive one or more pressure members 1439 therethrough.End walls 1415, 1416 include rails 1418 for slidably receiving rails1404 of side walls 1408, 1409. Frame structure 1425 comprises side walls1408, 1409 and opposing movable, pivotable or hinge members 1410, 1411.Hinged member 1410 comprises first and second hinge segments 1420, 1421.Hinged member 1411 comprises first and second hinge segments 1422, 1423.Hinge segments 1420, 1421 and hinge segments 1422, 1423 are movably,pivotally or hingedly connected to each other by way of side buttons1401, 1402 respectively at a pivot points so they can expand or collapsethe frame structure 1425, increasing or decreasing the distance betweensides or side walls 1408, 1409 of the frame structure 1425. The walls1408, 1409 may slide together into a closed or unstrained position(FIGS. 57A, 57C, 57E and 57F) or expand to an open or strained position(FIGS. 57B, 57D). Rails 1404 of walls 1408, 1409 engage rails 1418 tomaintain the walls 1408, 1409 of frame structure 1425 in alignment withthe frame structure 1424 when sliding back and forth.

Attachment structures 1406, 1407 are coupled to and move with side walls1408, 1409. In an unstrained configuration (FIGS. 57A, 57C, 57E and57F), the walls are a first shorter distance from each otherfacilitating loading of an unstrained skin treatment device. In astrained configuration (FIGS. 57B, 57D, 57G, 57H, 57I) the opposingwalls are a second greater distance from each other.

The moveable frame structure 1425 is further coupled to the stationarystructure 1424 with latching guide rods 1441 that are attached to sidebuttons 1401, 1402. Latching guide rods 1441 slide inward or outwardthrough guide slots 1443 in middle support structure 1417. Latchingguide rods 1441 serve to align movement of the hinge members 1410, 1411with respect to the frame structure 1424 and frame structure 1425.Latching guide rods 1441 include latch members 1442 at their distalends. The latch members 1442 engage catches 1444 at the ends of guideslots 1443 when the buttons 1401, 1402 are pushed in and the device isin a strained position.

FIGS. 57A, 57C, 57E and 57F illustrate the applicator 1400 in a first,unstrained position. The tensioning structure 1405 is in a collapsedposition. Hinge segments 1420, 1421 and side button 1401 are pivoted toform a convex or v-shape extending outward of the applicator, and hingesegments 1422, 1423 and side button 1402 are pivoted to form acollapsed, folded or v-shape extending outward of the applicator 1400 sothat the distance between end walls 1408, 1409 is relatively shorter.This facilitates loading of an unstrained skin treatment device. Afteran unstrained skin treatment device is loaded, it is strained byapplying pressure to the side buttons 1401, 1402. This forces hingesegments 1420, 1421 and hinge segments 1422, 1423 to pivotally move intoa straightened, elongated or open position as shown in FIGS. 57B and 57Dand thus transferring a separation force to the skin treatment device tostrain the skin treatment device.

The walls 1408, 1409, and hinge members 1410, 1411 form a box-likestructure with an opening 1429 through moveable frame structure 1425(when in the strained configuration) to provide access to a skintreatment device attached across the bottom of the applicator 1400 toattachment structures 1406, 1407. The stamper 1430 may be actuated toapply pressure by depressing the plunger 1432 to advance the pressuremembers 1439 through the opening 1429 and openings 1427, 1428 to a skintreatment device as or after it is being applied. As shown, the stamper1430 may be guided with guide posts 1447 fixed to middle supportstructure 1417. Guide posts 1447 are received by slots 1451 in plunger1432. Guide posts 1447 may include spring members 1449 that interactwith lip 1453 in slots 1451 to bias the stamper 1430 upward. Thisresists or prevents the pressure members 1339 from deploying withoutapplying a force and facilitates reloading by springing stamper 1430back in to a loading or unstrained position.

The device is shown in an open or unlocked position in FIGS. 57A, 57C,57E and 57F. When the device is in the strained position as shown inFIGS. 57B, 57D, 57G, 57H and 57I, buttons 1401, 1402 are pressed inwardand latching members 1442 on the guide rods 1441 engage with catches1444 in the T-bar 1470 (contiguous with the guide slots 1443) to lockthe buttons 1401, 1402 into place in a strained position. Springs 1449bias guides rods 1441 outward so that when the latch members 1442 arereleased from the catches 1444, the buttons 1401, 1402 spring open. Thelatching members 1442 remain latched until a sufficient stamping forceis applied as described below.

A T-bar release 1470 may be slidably positioned in the middle of middlesupport structure 1417. The T-bar 1470 may be biased upward by springmembers 1461 that are positioned over alignment pins 1462 for aligningT-bar 1470 over guide slots 1443. In an upward biased position, theT-bar has openings with catches 1444 that are contiguous with guideslots 1443. The tensioning member 1405 remains in the locked position,until the stamper 1430 is depressed, and a ceiling 1480 of the stamperengages the top of the t-bar 1470 to depress the T-bar 1470 typicallybiased upward by spring members 1461. The catches 1444 move downward torelease the latching member 1442 and the guide rods 1441 from lockingengagement with the catches 1444. When released, springs 1449 bias guiderods 1441 outward to thereby spring buttons 1401 1402 back into aloading or unstrained configuration.

Alternatively, without the stamper 1430, the opening 1429 may provideaccess to a user to apply pressure to a skin treatment device as orafter it is applied to a skin surface.

In a variation illustrated in FIGS. 57A to 57I, the attachmentstructures 1406, 1407 comprise a hook or loop mechanism. The applicatoror skin treatment device attachment structures may also comprise othertypes of attachment structures, including but not limited to otherattachment structures described or set forth herein.

Referring to FIGS. 58A to 58I, other variations of a tensioning device,straining device or applicator 1500 may include an integrated stamper1530 and release mechanism. The applicator 1500 comprises a firstpivoting frame portion 1501 a having a first handle member 1502 withlower frame portion 1504 and a second pivoting frame portion 1501 b witha second handle member 1503 with lower frame portion 1505. Attachmentstructures 1506, 1507 are respectively coupled to bottom of lower frameportions 1504, 1505. Attachment structures 1506, 1507 each comprise apivoting, or rotating structure, e.g. roller 1508 having an attachmentmechanism such as e.g., hooks or loops 1509 attached to a plurality oflocations on the roller 1508. The hooks or loops 1509 may be used toattached to a skin or wound treatment device such as, for example, asdescribed with respect to the skin treatment device 700 and attachmentdevices 716, 718, 732, 734 illustrated in FIGS. 47 and 48 herein.Alternative attachment structures may be used as discussed in furtherdetail herein.

The pivoting frame portions 1501 a, 1501 b are pivotally coupled byconnector 1510 to provide a pivot point 1512 to transfer force from theapplicator 1500 to a skin treatment device coupled to the attachmentstructures 1506, 1507, to thereby strain the skin treatment device priorto placement on skin.

FIGS. 58A and 58B illustrate an actuator or handle configuration priorto straining a skin treatment device for application to the skin of asubject. A skin treatment device may be attached to the attachmentstructures 1506, 1507. When an external force is applied to theactuator, e.g., the handle members 1502, 1503 of the applicator 1500 aresqueezed together, the force is transferred to provide a separationforce between the attachment structures 1506, 1507, coupled respectivelyto the bottom of the lower frame portions 1504, 1505. Optionally, thehandle may be provided with a distance from the top 1511 to the pivotpoint 1512 that is greater than the distance from the pivot point 1512to an attachment structure 1506 or 1507. Thus, the actuator or handlemay provide a mechanical advantage greater than 1 when actuated.

FIG. 58C schematically illustrates an actuator or handle configurationof the applicator 1500 where an attached skin treatment device 1557 isin a strained configuration prior to applying the stamper. The handlemembers 1502, 1503 have been squeezed together and a separation forcehas been exerted between the attachment structures 1506, 1507 to strainthe attached skin treatment device.

The applicator 1500 includes a mechanism to maintain the skin treatmentdevice in a strained configuration. Any of a variety of skin treatmentdevices may be used with this applicator 1500, including but not limitedto skin treatment devices illustrated in FIGS. 43A to 43C and othersdescribed herein. In accordance with a variation, the handle members1502, 1503 are releasably lockable together by a locking or latchingmechanism 1515 that prevents separation of the handle members 1502, 1503and thus the release of the strain exerted on the skin treatment device.As shown in FIG. 58B, the locking mechanism 1515 is depicted prior toclosure of the handle members 1502, 1503. Alignment pin 1521 of handle1503 fits into alignment opening 1520 of handle 1502. The lockingmechanism 1515 comprises a spring loaded latch 1516 that has a hook 1520that latches on to catch 1517 as the handle members 1502, 1503 close.The latch 1516 may be released by depressing release member 1518 tocompress spring 1519 and separating handle members 1502, 1503. Bylocking the applicator in a strained position, a predetermined strain ofa given skin treatment device may be achieved. Other locking mechanisms,including but not limited to other locking mechanisms described hereinmay be used. A variable locking mechanism may be used to vary the amountof strain for a given skin treatment device.

Pivoting frame portions 1501 a, 1501 b each further comprise guide slots1532 coupled to the lower frame portions 1504, 1505. When the handlemembers 1502, 1503 are coupled together, they form a plunger foractuating the stamper 1530. The stamper 1530 comprises handle members1502, 1503 which are attached to pressure members 1536 on their distalends. Slots 1532 are coupled to the lower frame members 1504, 1505 andpegs 1534 on the handle members 1502, 1503 are slidable within the slots1532.

When the device has been strained and the handle members have beenlatched (FIG. 58C) the dressing may be applied to the skin of a subject.The handle members 1502, 1503 that are coupled together may be depressedto apply a pressure to the back of the dressing with pressure members.Prior to stamping the dressing, detents 1533 within the guide slots 1532prevent the stamper from self-deploying by engaging with pegs 1534. Whenthe handle members 1502, 1503 are depressed, the force overcomes thedetents 1533 and the pegs 1534 slide distally through the slots 1532.The stamper 1530 applies pressure with pressure members 1536 to the skintreatment device 1557 to activate the adhesive.

The applicator 1500 may further includes releasable attachmentstructures 1506, 1507. According to a variation shown in FIGS. 58A to58I, the attachment structures 1506, 1507 each comprise lockablereleasable rollers 1508. The rollers 1508 are locked when loading andapplying a skin treatment device. They may be released to provide foreasy release of the attachment structures.

The release and locking structure 1550 comprises a release button 1551,pivoting lifter arms 1552, and fork members 1554 biased into a lockingposition (e.g. downward) with springs 1557. The pivoting lifter arms1552 are movably coupled to a first end of the fork members 1554. Forkmembers 1554 include roller engaging forks on the opposite end. Thelocking structure 1550 further comprises tabs 1556 on the rollers 1508that engage the fork members 1554 to lock the rollers 1508. The releasebutton 1551 has a lever end 1555 which may be pivotably moved with therelease button 1551 to actuate the pivoting lifter arms 1552, which thatin turn lift the attachment forks members 1554 from engagement with oneof the tabs 1556 on each of the rollers 1508.

To remove the applicator 1500 from the skin treatment device, after thestamper 1530 has been used to apply sufficient pressure to the skintreatment device, the release button 1551 may be lifted to release thefork members 1554 from tabs on the roller 1508. (FIGS. 58G to 58I) Theinternal strain on the skin treatment device places a tangential forceon the rollers 1508 causing them to rotate towards the skin treatmentdevice. This rotation replicates a peel motion that releases the Hookand loop connection.

Each roller 1508 has four tabs 1556 and four corresponding hook or loopmechanisms 1509. After the roller 1508 is released it rotates and thefork member 1554 engages an adjacent tab 1556 and an adjacent hook orloop mechanism 1509 is positioned on the bottom of the roller 1508 forreloading the next skin treatment device.

FIGS. 59A to 59C illustrate another variation of an applicator 1600.Applicator 1600 comprises a pair of spring or resilient members 1605.Each resilient member 1605 extends from attachment foot 1601 on a firstend 1602 to attachment foot 1603 on an opposite end 1604. Each resilientmember 1605 is positioned on sides 1608, 1609 of applicator 1600. Astamper 1610 is positioned between resilient members 1605. Stamper 1610includes handle 1611 comprising an arching member extending from firstend 1602 to second end 1604 and attached to planar support 1614. Thehandle 1611 is coupled to plunger 1612 attached to planar support 1614.A pressure member 1613 is attached to the bottom of the planar support1614. When the stamper 1610 is actuated, the pressure member 1613applies pressure to a strained skin treatment device attached to theattachment structures, 1606, 1607. Plunger 1612 has laterally extendingrods 1615 that prevent separation of the stamper 1610 from the resilientmembers 1605. As shown in FIG. 59A, the resilient members 1605 arecompressed to load an unstrained skin treatment device on to attachmentstructures 1606, 1607 which may comprise one or more variation ofattachment structures. The skin treatment device may be loaded on to acarrier that holds the resilient members until they are released tostrain the skin treatment device. The resilient members may also bemanually compressed and released to strain the skin treatment device.FIG. 59B shows the applicator 1600 in a strained configuration prior tostamping. FIG. 59C shows the applicator 1600 in a strained and stampedconfiguration.

FIGS. 60A to 60D illustrate variations of tensioning device, strainingdevice, or applicator 1650 in which the applicator 1650 isself-releasing from an applied skin treatment device. The applicator1650 comprises a handle 1651 and a resilient member 1654 coupled to thehandle 1651, attachment feet 1652 with upwardly curved ends 1653 andcoupling edges 1658, 1659, and attachment structures 1656, 1657 on thebottom of the attachment feet 1652. A skin treatment device 1660 for usewith the applicator is illustrated loaded on a carrier device 1670. Theskin treatment device has an adhesive side 1661; an attachment side1662; end portions 1664, 1665 with attachment features 1666, 1667 forattaching to attachment structures 1656, 1657 of the applicator 1650.The adhesive side 1661 is positioned on the carrier device 1670. Carrierdevice 1670 comprises a rigid planar backing 1671 with couplingstructures 1678, 1679 on each end. A releasable locking tab 1673 islocated on coupling structure 1678 to help peel or remove the carrier1670 from the skin treatment device 1660.

In use, the resilient member 1654 may be squeezed by hand to reduce thedistance between the attachment feet 1652 and to load a carrier 1670 andunstrained skin treatment device 1660 on to the applicator 1650. Thecoupling edges 1658, 1659 of the applicator engage with the couplingstructures 1678, 1679 of the carrier device 1670. The carrier device1670 maintains the skin treatment device 1660 in an unstrainedconfiguration until it is removed from the skin treatment device 1660.The locking tab 1673 is rotated upward to lock the skin treatment devicein an unstrained position. (FIG. 60A) To strain the skin treatmentdevice, the resilient member 1654 is released and then when the lockingtab 1673 is released by rotating it downward and the carrier 1670 isremoved from the skin treatment device. The resilient member 1652applies a separation force to strain the skin treatment device 1660which may then be applied to the skin of a subject. (FIG. 60B). Thedevice may then be released by rotating the applicator 1650 forward onto the curved ends 1653. (FIG. 60C) The removal feature may be used withvarious attachment structures including hook and loop combinedattachment structures. The applicator 1650 may also include a stamper1680 where the handle 1651 acts as a plunger handle and is used todepress stamper 1680 to apply pressure with pressure members 1681 (FIG.60D).

FIGS. 61A to 61F illustrate still another variation of a tensioningdevice, straining device or applicator 1700 in which the applicator 1700is self-releasing from an applied skin treatment device. The applicator1700 comprises a handle 1701 and a resilient member 1704 coupled to thehandle 1701, pivoting attachment feet 1702 coupled to the ends 1705 ofthe resilient member 1704. As shown in FIG. 61D, the resilient member1704 comprises a latch 1716 pivotally coupled to the each end portion1705 of the resilient member 1704. The latch 1716 includes a latchingfinger 1718 extending laterally outward of the resilient member 1704 anda release bar 1719 extending laterally inward of the resilient member1704. The resilient member also includes a resilient tab 1715 extendinglaterally outward from each end portion 1705. The pivoting attachmentfeet 1702 each comprise a hinge 1708 attached with a pin 1709 to an endportion 1705 of the resilient member 1704. The pivoting feet 1702 eachfurther comprise a planar bottom portion 1703 with attachment structures1706, 1707 thereon. The pivoting feet 1702 each further comprise alocking structure 1710 on the top of the feet 1702 having a top edge1711 for engaging a latching finger 1718 of a latch 1716, and a window1712 for receiving a tab 1715 extending laterally outward from each endportion 1705 of the resilient member 1704.

A stamper 1730, comprising a plunger handle 1731 which may be coupled toa T-bar 1732 which in turn is coupled to a backing 1733 with pressuremembers 1735. The backing 1733 may be configured to extend laterallyaround the pressure members 1735, at least around ends 1734 of backing1733. The stamper 1730 may be used to apply pressure to an applied skintreatment device with pressure members 1735.

In use, the resilient member 1704 is squeezed by hand to reduce thedistance between the pivoting feet 1702 and to load an unstrained skintreatment device 1720 on to the applicator 1700. The skin treatmentdevice 1720 has an adhesive side 1721; an attachment side 1722; endportions 1724, 1725 with attachment features 1726, 1727 for attaching toattachment structures 1706, 1707 of the applicator 1710. To strain theskin treatment device 1720, the resilient member 1704 is released. Theresilient member 1704 applies a separation force to strain the skintreatment device 1720 which may then be applied to the skin of asubject.

FIG. 61A shows a skin treatment device 1720 loaded onto and strained bythe applicator 1700 before the skin treatment device 1720 has beenstamped. The latch fingers 1718 of the latches 1716 are hooked over thetop edges 1711 of locking structures 1710 while receiving tabs 1715extend laterally outward from each end portion 1705 of the resilientmember 1704 and through windows 1712. (FIGS. 61A and 61D) The latchfingers 1718 hold the pivoting feet 1702 in a flat position and preventdownward rotation of the pivoting feet 1702. The tabs 1715 act asalignment pins and resist or prevent upward rotation of pivoting feet1702.

FIGS. 61B and 61F depict the stamper 1730 depressed. The stamper 1730releases the pivoting feet 1702 and attachment structures 1706, 1707from engagement with the attachment features 1726, 1727 of the skintreatment device 1720. When the stamper 1730 is depressed, the pressuremembers 1735 apply pressure to the back of the skin treatment device andthe ends 1734 of backing 1733 engage the release bars 1719 moving themdown and lifting the latching finger 1718 which permits the pivotingfeet 1702 to rotate down as the plunger handle 1731 is pulled up toremove the applicator 1700 from the skin treatment device 1720. As thepivoting feet 1702 are released, both feet 1702 pivot inward due to theinternal strain in the skin treatment device. This rotational motionbreaks the contact between the hook and loop of attachment structures1706, 1707 and attachment features 1726, 1727, at a lower force allowingthe applicator 1700 to detach without substantially pulling the skintreatment device 1720 off of the skin or reducing the amount the skintreatment device may be pulled off of the skin. The removal feature maybe used with various attachment structures including hook and loopcombined attachment structures.

FIGS. 62A to 62D illustrate an example of a self-expanding tensioningdevice, straining device or applicator 1750. The applicator 1750comprises opposing end supports or bars 1752 have a fixed shape andopposing sliding side bars 1754. Bars 1752, 1754, form an open framestructure 1751 with opening 1769. Each of side bars 1754 comprises aninner tube 1755 with an end 1756 that slides within an outer tube 1757.A spring 1758 is positioned in each outer tube 1757 and interfaces withend of inner tube 1755 to bias inner tube 1755 and outer tube 1757apart. Stationary end bars 1752 have attachment structures 1753 alongthe bottom.

A loader or dispenser 1760 comprises a planar bottom 1761 and side walls1762 forming an open box. The box is sized to receive an unstrained skintreatment device 1770 having attachment features 1772 for engaging withattachment structures 1753 of the applicator 1750. As shown in FIG. 62A,an unstrained skin treatment device 1770 is placed within the loader1760 with the attachment features 1772 facing up. The side bars 1754 ofthe applicator 1750 are compressed together and the applicator 1750 isplaced within loader 1760 with the end bars 1752 and sliding side bars1754 engaging the inside of side walls 1762 to prevent the side bars1754 from sliding open. Attachment structures 1753 of applicator 1750are facing down and aligned with the attachment features 1772 of theskin treatment device 1770 so that they are coupled together. As shownin FIG. 62B, the applicator 1750 and skin treatment device 1770 areremoved from the loader 1760 and as shown in FIG. 62C, the applicator1750 self-expands with biasing force of springs 1758 and strains theattached skin treatment device 1770 by applying a separating force. Theskin treatment device 1770 is then applied to the skin of a subjectusing applicator 1750, and as shown in FIG. 62D, the applicator 1750 isseparated from the skin treatment device 1770.

FIGS. 63A and 63B illustrate a variation of an attachment system 2000 toattach a skin treatment device to an applicator or tensioning device andto strain the skin treatment device that includes an attachmentstructure for an applicator or tensioning device and an attachmentfeature for a skin treatment device. The attachment system includespockets 2005 that are formed on and extend the length of the sides 2011of a skin treatment device 2010. The pockets 2005 may be formed byfolding over edges of the skin treatment device and bonding the folds onthe outer edges and at various points along the length to form aplurality of pocket portions 2005 a. An attachment structure 2003 thatmay be used on an applicator or tensioning device in accordance with oneor more variations of an applicator or tensioning device is showncomprising a side 2015 with a plurality of tabs 2012 or a plurality ofcutouts 2014. In use, an applicator or tensioning device has a pluralityof attachment structures 2003 which are placed in a plurality of pockets2005 of a skin treatment device 2010. The tabs 2012 fit into pocketportions 2005 a. A separation force is applied with attachmentstructures 2003 to the skin treatment device to strain it in one or moredirections. In accordance with variations of the invention, multipletabs or fingers may be provided on the attachment structures to adapt orconform to uneven or undulating skin.

FIGS. 64A to 64E illustrate variations of an attachment system to attacha skin treatment device to an applicator or tensioning device and tostrain the skin treatment device that includes an attachment structurefor an applicator or tensioning device and an attachment feature for askin treatment device. A skin treatment device 2030 is pre-mounted toplastic feet 2025 which may be attached to the skin treatment device2030 in one of several manners. For example, the plastic feet 2025 maybe inserted into a pocket, or attached by a hook or loop mechanism orother attachment structure. The plastic feet 2025 have notchedattachment pegs 2026 that are easily accessible to a tensioning deviceor applicator. Any one or more of the applicators described herein maybe used, for example. FIG. 64B shows an applicator 2022 with attachmentstructures 2023 comprising mating features 2024 for snapping pegs 2026on to applicator 2022. The applicator then applies a separation force tothe plastic feet to strain the skin treatment device 2030. Theapplicator may apply the separation force a variety of ways includingbut not limited to those described in the various embodiments herein.FIG. 64B shows pivot arms that may be pivoted e.g. using a handle toexert a separation force.

FIG. 64C illustrates variations of system that includes an attachmentstructure for an applicator or tensioning device and an attachmentfeature for a skin treatment device. Attachment structure 2024 acomprises a spring biased hook 2024 a that may hook on to a wire loop2026 a on a plastic foot 2025 a.

FIG. 64D illustrates an alternative attachment system that includes anattachment structure for an applicator or tensioning device and anattachment feature for a skin treatment device. Attachment structure2030 comprises an angled attachment feature 2036 that engages an angledattachment feature 2035 of a skin treatment device.

FIG. 64E illustrates an alternative attachment system that includes anattachment structure for an applicator or tensioning device and anattachment feature for a skin treatment device. Attachment structure2040 comprises an angled attachment feature 2046 that engages an angledattachment feature 2045 of a skin treatment device. Angled attachmentfeature 2046 is coupled to a spring mechanism 2041 that biases theattachment feature 2046 and attachment feature 2045 downward. This mayassist in applying a skin treatment device to an uneven area of skin orbody profile.

FIGS. 64F to 64I illustrate an alternative attachment system thatincludes an attachment structure for an applicator. The applicator 2060includes attachment structures 2066 coupled by way of torsion springs orspring loaded pivots 2063 to the applicator 2060. Each attachmentstructure 2066 comprises a convex foot 2068 with hooks (of a hook andloop attachment mechanism). In FIGS. 64F and 64H, a skin treatmentdevice 2070 is loaded onto attachment structures 2066 and the springloaded pivot 2063 is locked in position using a locking mechanism forexample as described herein. The convex foot 2068 may serve to apply agenerally more uniform pressure on the skin treatment device 2070 whenapplied to uneven skin. As shown in FIGS. 64H and 64I, the attachmentfeature 2071 on the skin treatment device 2070 comprises a loop (of ahook and loop mechanism). When the spring loaded pivots 2063 arereleased, the convex feet 2068 rotate so that fewer rows of hooks arepeeled from the loop at a time to reduce the required force at the timeof removal, release or detachment of the hooks form the loops or of theattachment structures 2066 of the applicator 2060 from the attachmentfeatures 2071 of the skin treatment device 2070.

FIGS. 64J and 64K illustrate variations of an attachment system for atensioning device, straining device or applicator. Attachment structure2075 comprises a roller 2076 that may be locked and unlocked in a mannersimilar to roller 1508 as described with respect to FIGS. 58A to 58I.The roller 2076 comprises a plurality of attachment fingers 2077 forengaging openings or pockets in a skin treatment device. As shown inFIG. 64J, fingers 2077 may be positioned in openings 2079 of skintreatment device 2078. In the loaded and locked position, the roller2076 is positioned with the fingers 2077 facing away in a horizontalplane from the middle of the skin treatment device 2078. After the skintreatment device 2078 is applied, the rollers 2076 are released,unlatched or unlocked. The internal tension of the strained skintreatment device pulls or rotates, the fingers 2077 and roller 2076 in amanner that translates the fingers so they are closer to perpendicularto the skin and the attachment structure 2075 can be removed from theskin treatment device.

FIGS. 64L and 64M illustrate variations of an attachment system for atensioning device, straining device or applicator. As shown in FIG. 64L,a linked locking bar 2081 is coupled to a translating foot 2082 withhook or loop material 2083, in a locked position facing an attachmentfeature 2086 of a skin treatment device 2085. As shown in FIG. 64M, thelinked locking bar 2081 is pulled up and out of the locking position,for example using lifter arms 1552 as described with respect to FIGS.58A to 58I. The translating foot 2082 which is moved by the locking bar2081 to a position more perpendicular with respect to attachment feature2086 of a skin treatment device 2085.

FIGS. 65A to 65C illustrate variations of system that includes anattachment structure for an applicator or tensioning device and anattachment feature for a skin treatment device. An attachment structuresystem 2100 is illustrated having an attachment structure 2106comprising attachment tabs 2107 at the end of a sliding planar member2108 that slides within slot 2103 of housing wall 2102. Button 2104 isattached to the outside of the housing wall 2102 extends into housingwall 2102 and is attached to the sliding planar member 2108. The buttonis slidable up and down in the housing wall to extend or retract thetabs 2107 at the end of the sliding planar member. In use, the tabs 2107extend out of the housing wall and are used to engage an attachmentstructure such as, e.g. a pocket, of a skin treatment device (not shown)in a manner similar to that described with respect to attachmentstructure 2003 and skin treatment device 2010 of FIG. 63A. A secondattachment structure system (not shown) attaches to an attachmentstructure on another side of the skin treatment device. A separationforce is applied through the attachment systems to strain the skintreatment device. After the strained skin treatment device is applied tothe skin, the buttons 2104 on each housing wall of each attachmentsystem 2100 may be used to retract the attachment structures to providefor release, removal or detachment of the applicator or straining devicefrom the skin treatment structure.

FIGS. 66A to 66B illustrate a skin frame 2200 configured to pre-strainskin prior to application of a skin treatment device to the skin thatwill hold the skin in a strained configuration. The frame 2200 comprisesan inner sliding frame 2201 and an outer sliding frame 2202. Attachmentstructure 2206 is attached to the bottom of inner sliding frame 2201 ona first side 2203 of the skin frame 2200. Attachment structure 2207 isattached to the bottom of the outer sliding frame 2202 on a second side2204 of the skin frame 2200. The attachment structures 2206, 2207 areconfigured to attach to skin, for example by way of adhesive, frictionpads, microneedles and the like. The friction pads may comprise asilicone, a viscoelastic polymer such as styrenic block polymers, andthe like. In use, the attachment structures 2206, 2207 are attached toskin when the skin frame is in the first position as shown in FIG. 66A.In the first position the distance between the attachment structures isL1. As shown in FIG. 66B, the sides 2203, 2204 of the skin frame areslid together by sliding inner frame 2201 and outer frame 2202 withrespect to each other. Thus the distance between the attachmentstructures is L2 where L2 is less than L1, thus straining the skin towhich the attachment structures 2206, 2207 are attached. A skintreatment device may then be placed through opening 2205 of the skinframe. The skin treatment device is configured to hold the skin inplace. The skin treatment structure may be an unstrained or a strainedtreatment structure. For example such as the dressings, wound treatmentdevice or skin treatment devices described herein or use with anapplicator.

While the particular examples illustrated and described herein includespecific combinations of the variety of features described herein, oneof skill in the art will understand that other combinations of featuresdescribed herein are contemplated. For example, Applicators 100, 200,220, 240, 260, 280, 300, 320, 714, 730, 70, 900, 1000, 1100, 1200, 1250,1300, 1400, 1500, 1600, 1650, 1700 and 1750 are each depicted with aparticular attachment mechanism but may also be designed with otherattachment mechanisms (e.g. those shown in skin treatment devices 2,600, 630, 650, 660, 670, 680, 700, or attachment mechanisms depicted inFIGS. 64C to 64M). Likewise, applicators comprising a stamper may alsobe configured without a stamper and provided with an access opening topermit direct pressing of a skin treatment device by the user.

In another variation, the device may be applied without an applicator bygrasping the flap regions and manually stretching the device. Thestretched device may then be applied to the skin and allowed to recover.In still another variation, instead of pre-stretching the device, theunderlying skin may be pre-compressed while an unstrained device isadhered or attached to the compressed skin. Once attached, thecompressive force acting on the skin may be removed to permit transferand equilibration of the skin compression to tensile strain acting onthe device.

To facilitate removal of the device, an outer edge of the device may belifted and slowly peeled off, working toward the midline or incisionsite. In some examples, water, isopropyl alcohol or other adhesiveremoval agent may be administered to the device/skin interface tofacilitate removal. The same agent may also be used to remove anyremaining adhesive found on the skin after complete removal of thedevice. If another device is to be applied to the same site, the skinmay be dried before the replacement device is applied.

While this invention has been particularly shown and described withreferences to embodiments thereof, it will be understood by thoseskilled in the art that various changes in form and details may be madetherein without departing from the scope of the invention. For all ofthe embodiments described above, the steps of the methods need not beperformed sequentially.

What is claimed as new and desired to be protected by Letters Patent ofthe United States is:
 1. A skin treatment system, comprising: an elasticsheet, comprising: a skin adhesive on a first surface of the elasticsheet; a first attachment structure comprising at least one opening; asecond attachment structure comprising at least one opening; and atensioning member comprising a first attachment end and a secondattachment end configured to releasably couple to the first attachmentstructure and to the second attachment structure, respectively; andwherein the tensioning member is configured to exert a separation forcebetween the first and second attachment structures to strain the elasticsheet, and is removable to release the separation force.
 2. The systemof claim 1, wherein at least one of the first and second attachmentstructures comprises a pocket configured with the at least one openingof the first or second attachment structure.
 3. The system of claim 1,wherein the at least one opening of at least one of the first and secondattachment structures is configured to receive at least one of the firstand second attachment ends of the tensioning member.
 4. The system ofclaim 1 wherein the first attachment structure and the second attachmentstructure are located on an opposite surface to the first surface of theelastic sheet.
 5. The system of claim 1, further comprising a releasablelocking mechanism configured to maintain the tensioning member in afirst configuration.
 6. The system of claim 5, wherein the firstconfiguration is a strained configuration.
 7. The system of claim 5,wherein the releasable locking mechanism comprises a releasable latch.8. The system of claim 7, wherein the releasable locking mechanism isconfigured to lock at a pre-determined strain of the elastic sheet. 9.The system of claim 5, wherein the locking mechanism is configured tolock across a range of tensioning member configurations corresponding toa range of predetermined strains in the elastic sheet.
 10. The system ofclaim 9, wherein the locking mechanism is configured to lock across arange of predetermined strains within a range from about 0% to about60%.
 11. The system of claim 9, wherein the locking mechanism isconfigured to lock across a range of predetermined strains within arange from about 10% to about 50%.
 12. The system of claim 1, whereinthe tensioning member comprises a spring.
 13. The system of claim 1,wherein the tensioning member comprises a mechanical force applicatorconfigured to exert the separation force.
 14. The system of claim 13,wherein the mechanical force applicator provides a mechanical advantageto apply the force.
 15. The system of claim 13, wherein the mechanicalforce applicator is manually actuatable.
 16. The system of claim 1,wherein the tensioning member comprises an elastic body configured toreleasably couple to the first attachment structure and to the secondattachment structure, and to stretch the elastic sheet upon release ofpotential energy from the elastic body, and wherein the elastic body isremovable to release the separation force.
 17. A skin treatment system,comprising: an elastic sheet, comprising: a skin adhesive on a firstsurface of the elastic sheet; a first attachment structure; a secondattachment structure; and a tensioning member comprising a firstattachment end and a second attachment end configured to releasablycouple to the first attachment structure and to the second attachmentstructure, respectively; and wherein the tensioning member is configuredto exert a separation force between the first and second attachmentstructures to strain the elastic sheet, and is removable to release theseparation force; and wherein one of the first attachment structure orthe first attachment end comprises at least one opening to receive theother of the first attachment structure and the first attachment end,and wherein one of the second attachment structure or the secondattachment end comprises at least one opening to receive the other ofthe second attachment structure or the second attachment end.